510(k) · Cleared

Cleared

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

K191212510(k) TraditionalCleared Sep 24, 2019141-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medos International SARL · PGM Growing Rod System

Cleared on Sep 24, 2019 as substantially equivalent to K160904 (Medos International SARL, 2016) and 68 other predicates after a 141-day review. Its family tree reaches back 17 generations to 2004.

Decided: Sep 24, 2019
Review: 141 days
Class: Class II
Product code: PGM
Recalls: None
Predicates: 69

Its longest line of descent runs back 17 generations to K040583 (2004). 223 ancestors in all, the oldest K760649 (1976). No later device cites it as a predicate yet.

By dateBy generation

Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
13 generations between
3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
2 generations backK171570 Additional VIPER PRIME™ screws with fenestrationsMedos International SARL · 2017
1 generation backK173095 VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations…Medos International SARL · 2017
This deviceK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019

Show all 17 generations

Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
5 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
4 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
2 generations backK171570 Additional VIPER PRIME™ screws with fenestrationsMedos International SARL · 2017
1 generation backK173095 VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations…Medos International SARL · 2017
This deviceK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−17	K040583	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
−16	K041118	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
−15	K042025	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2004	4
−14	K043151	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2005	—
−13	K050809	CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2005	—
−12	K052187	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2005	—
−11	K053101	CD Horizon Spinal System	Medtronic Sofamor Danek	2006	—
−10	K091442	CD Horizon Spinal System	Medtronic Sofamor Danek	2009	—
−9	K091974	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2009	1
−8	K102555	CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2010	—
−7	K112473	CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2011	—
−6	K113174	CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2011	1
−5	K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	Medtronic Sofamor Danek USA, Incorporated	2016	—
−4	K160879	CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated…	Medos International Sàrl	2016	—
−3	K170543	VIPER PRIME™ Screws with Fenestrations	Medos International SARL	2017	—
−2	K171570	Additional VIPER PRIME™ screws with fenestrations	Medos International SARL	2017	—
−1	K173095	VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse…	Medos International SARL	2017	—
0 (this device)	K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM…	Medos International SARL	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1976	1	0
1984	1	0
1985	1	0
1988	1	0
1989	2	0
1990	1	0
1991	2	0
1992	2	0
1993	4	0
1994	1	0
1995	8	0
1996	8	0
1997	6	0
1998	15	0
1999	10	0
2000	13	0
2001	21	0
2002	12	0
2003	12	0
2004	22	0
2005	15	0
2006	12	0
2007	8	0
2008	8	0
2009	3	0
2010	5	0
2011	5	0
2012	3	0
2014	1	0
2015	1	0
2016	2	0

FIG. 1 — Lineage of K191212, 2004–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PGM device

#1 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (69)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K160904	Expedium Spine System, VIPER and VIPER 2 Systems Summary page 12 …ss II - 21 CFR §888.3060 Spinal intervertebral body fixation orthosis NKB — Class I1 - 21 CFR §888.3070 Thoracolumbosacral pedicle screw system EXPEDIUM® Spine System (K160904) CrossOver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw Sy…	Medos International SARL	2016	—
*	K012971	Isola Spinal Systems Summary page 12 …ertebral body fixation orthosis NKB — Class I1 - 21 CFR §888.3070 Thoracolumbosacral pedicle screw system EXPEDIUM® Spine System (K160904) CrossOver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross C…	Depuyacromed	2001	—
*	K021879	Crossover Cross Connector (Isola Spinal System) Summary page 12 …body fixation orthosis NKB — Class I1 - 21 CFR §888.3070 Thoracolumbosacral pedicle screw system EXPEDIUM® Spine System (K160904) CrossOver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors…	Depuyacromed	2002	—
*	K113396	Depuy Pulse Thoracolumbar Screw System Summary page 12 …88.3070 Thoracolumbosacral pedicle screw system EXPEDIUM® Spine System (K160904) CrossOver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System…	Medos International SARL	2012	—
*	K160879	CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems Summary page 12 …m EXPEDIUM® Spine System (K160904) CrossOver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Co…	Medos International Sàrl	2016	—
*	K111136	Expedium Spine System, Viper System, Viper 2 System Summary page 12 …ver Cross Connectors (K012971, K021879) DePuy PULSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K0…	Depuy Spine, Inc.	2012	1
*	K142185	Expedium Verse Spine System Summary page 12 …LSE Thoracolumbar Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K89544…	Depuy Spine, Inc.	2014	—
*	K173095	VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with… Summary page 12 …Screw System (K113396) EXPEDIUM® Fenestrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K90582…	Medos International SARL	2017	—
*	K001372	E-Z Link Cross Connector Summary page 12 …estrated Screw System (K160879) EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices s…	Depuyacromed	2000	—
*	K003822	Isola Closed Dual Rod Connector Summary page 12 …EXPEDIUM® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA…	Depuyacromed	2001	—
*	K010972	Isola Band Clamp Summary page 12 …M® SFX® Cross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product…	Depuyacromed	2001	—
*	K013441	Isola Polyaxial Washer Summary page 12 …ross Connectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code clas…	Depuyacromed	2001	—
*	K022285	Modification to Isola Spinal System Summary page 12 …ectors (K111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classificatio…	Depuyacromed	2002	—
*	K884163	Acromed Spinal Rod and Spinal Hooks Summary page 12 …111136, K160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. Howev…	Buckman Co., Inc.	1989	—
*	K895441	Acromed Button Spinal Wire Summary page 12 …160904) EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. However, have…	Acromed Corp.	1989	—
*	K905184	Isola (TM) Spine System Top Entry Hook Summary page 12 …EXPEDIUM VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. However, have previousl…	Acromed Corp.	1991	—
*	K905826	Isola Slotted Connect/Angled Slotted Connector Summary page 12 …VERSE® Spine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. However, have previously been cl…	Acromed Corp.	1991	—
*	K921090	Isola (R) Transverse Rod Dual Connector Summary page 12 …ine System (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. However, have previously been cleared by…	Acromed Corp.	1992	—
*	K922504	Isola (R) Tandem Connector Summary page 12 …m (K142185, K160879, K173095) E-Z Link Cross Connectors (K001372) ISOLA® Spine System (K003822, K010972, K013441, K022285, K884163, K895441, K905184, K905826, K921090, K922504, ! The devices subject to JDQ are non-spine FDA product code classifications. However, have previously been cleared by other com…	Acromed Corp.	1993	—
*	K922952	Songer Cable System Summary page 13 …ct to JDQ are non-spine FDA product code classifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K0105…	Pioneer Surgical Technology	1993	—
*	K943819	Isola Anterior System Summary page 13 …are non-spine FDA product code classifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K0211…	Acromed Corp.	1995	—
*	K944737	Isola Spine System Summary page 13 …spine FDA product code classifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K0234…	Acromed Corp.	1995	—
*	K951116	Acromed Pedicle Screw Summary page 13 …product code classifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K0243…	Acromed Corp.	1995	—
*	K952236	Isola System Summary page 13 …code classifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K1111…	Acromed Corp.	1996	—
*	K962645	Isola Twister Connector Summary page 13 …sifications. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS…	Acromed Corp.	1996	—
*	K964007	Acromed Cable/Wire Pedicle Screw Summary page 13 …ns. However, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI S…	Acromed Corp.	1996	—
*	K971248	Kaneda SR Anterior Spinal System Summary page 13 …er, have previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine Syst…	Acromed Corp.	1997	—
*	K974757	Kaneda Anterior Scoliosis System Kass Summary page 13 …previously been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K0011…	Acromed Corp.	1998	—
*	K980485	Isola Spinal System Summary page 13 …y been cleared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K0026…	Acromed Corp.	1998	—
*	K981113	Pediatric PRC Summary page 13 …eared by other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K0107…	Acromed Corp.	1998	—
*	K984350	VSP System Summary page 13 …other companies for spinal use. K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO111…	Depuy Motech Acromed	1999	—
*	K010576	Monarch Spine System Summary page 13 …K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K1…	Depuyacromed	2001	—
*	K021148	Monarch Spine System Commercially Pure Titanium Spinal Rod Summary page 13 …13 === K191212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K7…	Depuyacromed	2002	—
*	K023438	Modification to Monarch Spine System Summary page 13 …91212 Page 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K8…	Depuyacromed	2002	—
*	K024348	Monarch Spine System Summary page 13 …e 3 of 10 K922952, K943819, K944737, K951116, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K9…	Depuyacromed	2003	—
*	K001105	Moss Miami 6.35MM Rod System Pedicle and Laminar Hooks Summary page 13 …, K952236, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K9…	Depuyacromed	2000	—
*	K002607	Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral… Summary page 13 …, K962645, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K9…	Depuyacromed	2000	—
*	K010742	Moss Miami 5.5MM Titanium Pin Nut Summary page 13 …, K964007, K971248, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K9…	Depuyacromed	2001	—
*	K011182	Modified Moss Miami 4.35MM Diameter Polyaxial Screws	Depuyacromed	2001	—
*	K022623	5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) Summary page 13 …, K974757, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K9…	Depuyacromed	2002	—
*	K023804	Moss Miami Spinal System Pin Nut Summary page 13 …, K980485, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K9…	Depuyacromed	2003	—
*	K030383	Modification to Moss Miami Spinal System Polyaxial Screws Summary page 13 …, K981113, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K9…	Depuyacromed	2003	—
*	K103490	Expedium Spine System, Moss Miami Spine System Summary page 13 …, K984350) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K9…	Johnson & Johnson	2011	—
*	K760649	Total Spinal Correction Summary page 13 …) MONARCH® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) T…	Depuy, Inc.	1976	—
*	K894184	Biedermann Motech Universal Spinal System Summary page 13 …H® Spine System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low B…	Biedermann Motech GmbH	1990	—
*	K933881	Depuy Motech Moss-Miami Spinal System Summary page 13 …System (K010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back Syste…	Depuy, Inc.	1994	—
*	K950695	Depuy Motech Moss Spinal System - Pedicle Fixation Summary page 13 …010576, K021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K98434…	Depuy Motech	1995	—
*	K953915	Moss Miami Spinal System (Anterior Use) Summary page 13 …021148, K023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER…	Depuy, Inc.	1996	—
*	K955348	Titanium Moss Miami Spinal System Summary page 13 …023438, K024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestr…	Depuy, Inc.	1996	—
*	K962628	Moss Miami Spinal System Summary page 13 …024348, K111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Scre…	Depuy, Inc.	1997	—
*	K964024	Depuy Motech Titanium Moss Miami Spinal System Summary page 13 …111136) MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System…	Depuy, Inc.	1997	—
*	K972568	Depuy Motech Moss-Miami Spinal System Summary page 13 …MOSS® MIAMI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879)…	Depuy, Inc.	1997	—
*	K980447	Depuy Motech Moss Miami Spinal System Summary page 13 …MI Spine System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER P…	DePuy Orthopaedics, Inc.	1998	—
*	K982011	Depuy Motech Moss Miami Spinal System Summary page 13 …System (K001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ Sys…	DePuy Orthopaedics, Inc.	1998	—
*	K982320	Depuy Motech Moss Miami Spinal System Summary page 13 …001105, K002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162…	Depuy, Inc.	1998	—
*	K983583	Depuy Acromed Moss and Moss Miami Spinal Systems Summary page 13 …002607, K010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173…	Depuy, Inc.	1998	—
*	K984378	Depuy Acromed Moss Spinal System Summary page 13 …010742, KO11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIP…	Depuy, Inc.	1998	—
*	K992168	Moss Miami 6.35MM Polyaxial Screw Summary page 13 …O11182, K022623, K023804, K030383, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™…	Depuyacromed	1999	—
*	K984348	Timx Low Back System Summary page 13 …3, K103490, K760649, K894184, K933881, K950695, K953915, K955348, K962628, K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K1…	Depuy Motech Acromed	1999	—
*	K162912	VIPER PRIME™ additions to the VIPER® System Summary page 13 …K964024, K972568, K980447, K982011, K982320, K983583, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER®…	Medos International SARL	2016	—
*	K170543	VIPER PRIME™ Screws with Fenestrations Summary page 13 …3, K984378, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571…	Medos International SARL	2017	—
*	K171570	Additional VIPER PRIME™ screws with fenestrations Summary page 13 …8, K992168) TiMX Low Back System (K984348) VIPER® Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904…	Medos International SARL	2017	—
*	K121020	Viper System Summary page 13 …Fenestrated Screw System (K160879) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine S…	Depuy Spine, Inc.	2012	—
*	K101993	Viper System, Expedium System Summary page 13 …) VIPER PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236,…	Depuy Spine, Inc.	2010	8
*	K102701	Viper Spine System Summary page 13 …PRIME™ System (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236, K965102,…	Depuy Spine, Inc.	2010	—
*	K110216	Expedium System, Viper System Summary page 13 …stem (K162912, K173095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236, K965102, K980485,…	Depuy Spine, Inc.	2011	—
*	K111571	Viper Systems Summary page 13 …3095) VIPER PRIME™ Fenestrated Screws (K170543, K171570, K173095) VIPER® SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236, K965102, K980485, K984350) E. Submi…	Johnson & Johnson	2011	—
*	K944736	VSP (Variable Screw Placement) Summary page 13 …SAI (Sacral-Alar-Iliac) (K121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236, K965102, K980485, K984350) E. Submission Purpose Obtain clearance for magnetic resonance compatibility label…	Acromed Corp.	1995	—
*	K965102	Acromed Pedicle Screw Summary page 13 …121020, K160904) VIPER® System (K101993, K102701, K110216, K111136, K111571, K160904) VIPER® 2 System (K111136, K160904) VSP® Spine System (K944736, K951116, K952236, K965102, K980485, K984350) E. Submission Purpose Obtain clearance for magnetic resonance compatibility labeling of the systems listed.…	Acromed Corp.	1997	1

Also cleared against K160904: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 4 months on median.
20 of the 223 ancestors have a recall of any class.
4 other devices also cite its predicate K160904.

How does its category compare?

All PGM devices

PGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PGM

1in 2025

2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGM

81in 2014

2007high 81 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PGM

No recall names PGM since 2007.

Adverse event reports per year · PGM

7in 2025

2007high 9 (2016) · low 0 (2007)2025

MAUDE reports naming product code PGM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	4	81	5
2015	1	—	1
2016	1	—	9
2017	1	—	4
2018	2	—	1
2019	1	—	0
2020	1	—	1
2021	0	—	0
2022	1	—	5
2023	0	—	3
2024	0	—	1
2025	1	—	7
2026	1	—	—

What is it indicated for?

The DePuy PULSE Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications…

Read the full statement (987 words)

The DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOLA, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA, VSP, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in posterior spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM, VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and TiMX Spine Systems. Please refer to the labeling of the aforementioned spinal systems for each system's indications for use.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System and VIPER 2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, and VIPER PRIME are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with the CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K191212 · printed Nov 6, 2026

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510(k) Report. “K191212: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191212

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026