510(k) · Cleared

Cleared

Medyssey Cannulated Pedicle Screw

K121670510(k) TraditionalCleared Jan 25, 2013233-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

Medyssey Co, Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 25, 2013 as substantially equivalent to K103272 (Medyssey Co, Ltd., 2010) and 17 other predicates after a 233-day review. Its family tree reaches back 9 generations to 1999. 1 of the 120 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.

Decided: Jan 25, 2013
Review: 233 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 18

Its longest line of descent runs back 9 generations to K990745 (1999). 108 ancestors in all, the oldest K933881 (1994). 11 later devices descend from it, 3 citing it directly. 1 of the 120 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
5 generations between
3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
This deviceK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
Descendant · cites it directly · 8 of its ownK131878 Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013
Descendant · 2 generations on · 5 of its ownK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
Descendant · 3 generations on · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
Descendant · cites it directly · 2 of its ownK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
Descendant · 3 generations on · 1 of its ownK171509 Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017

Show all 9 generations

Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
4 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
This deviceK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013high 3 (2017) · low 0 (2014)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix Systemdirect predicate · 2010

Most influential descendants

Showing 5 of 11 · See all

K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013 · cites it directly8descendants
K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015 · 2 generations on5descendants
K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · 3 generations on2descendants
K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017 · cites it directly2descendants
K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
−8	K992739	Click'x	Synthes Spine	2000	1
−7	K040442	Protex Stabilization System	Globus Medical, Inc.	2004	—
−6	K052069	Protex Stabilization System with Additional Componentes	Globus Medical, Inc.	2005	—
−5	K061202	Revere Stabilization System	Globus Medical, Inc.	2006	—
−4	K081195	Revere Uniplanar Screws	Globus Medical, Inc.	2008	—
−3	K091782	Revere 6.35 Stabilization System	Globus Medical, Inc.	2009	—
−2	K093294	Revere Stabilization System	Globus Medical, Inc.	2010	—
−1	K100788	Cocr Rods	Globus Medical, Inc.	2010	—
0 (this device)	K121670	Medyssey Cannulated Pedicle Screw	Medyssey Co, Ltd.	2013	—
+1	K131878	Lliad, Kora, Zenius Pedicle Screw System	Medyssey USA, Inc.	2013	—
+2	K142835	Iliad Pedicle Screw System and Zenius Pedicle Screw System	Medyssey USA, Inc.	2015	—
+3	K222229	Advanced LumFix Spinal Fixation System	CG Bio Co., Ltd.	2023	—
+1	K171526	Zenius™, lliad™ and Kora™ Spinal Fixation Systems	Medyssey USA, Inc.	2017	—
+3	K171509	Iliad® Pedicle Screw System and Zenius® Pedicle Screw System	Medyssey USA, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1996	1	0
1997	2	0
1998	4	0
1999	1	0
2000	9	0
2001	6	0
2002	9	0
2003	11	0
2004	9	0
2005	10	0
2006	5	0
2007	8	0
2008	7	0
2009	7	0
2010	6	1
2011	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2017	3	0
2018	1	0
2020	1	0
2023	3	0
2025	1	0

FIG. 1 — Lineage of K121670, 1999–2025Source: 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.

1 device in this family has a Class I recall. 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 NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (18)

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
*	K103272	Zenius Spinal System Summary page 1 …H, NKB Classification Name: Noncervical, Pedicle Screw System Regulation Number: 21 CFR 888.3070 Predicate Device: Medyssey Co. Ltd, Zen/us Tm Spinal System K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes…	Medyssey Co, Ltd.	2010	—
*	K110283	Zenius Spinal System Summary page 1 …ification Name: Noncervical, Pedicle Screw System Regulation Number: 21 CFR 888.3070 Predicate Device: Medyssey Co. Ltd, Zen/us Tm Spinal System K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matr…	Medyssey Co, Ltd.	2011	—
*	K081153	Novel Spinal System Summary page 1 …mber: 21 CFR 888.3070 Predicate Device: Medyssey Co. Ltd, Zen/us Tm Spinal System K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere…	Medyssey Co, Ltd.	2009	—
*	K103147	Novel Iii Spinal Fixation and Adjustable Bridge System Summary page 1 …21 CFR 888.3070 Predicate Device: Medyssey Co. Ltd, Zen/us Tm Spinal System K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere…	Medyssey Co, Ltd.	2010	—
*	K110284	Novel Iii Spinal Fixation and Adjustable Bridge System Summary page 1 …70 Predicate Device: Medyssey Co. Ltd, Zen/us Tm Spinal System K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere…	Medyssey Co, Ltd.	2011	—
*	K092929	Synthes Matrix System Summary page 1 …em K1 03272 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K1007…	Synthes (Usa)	2009	1
*	K100634	Synthes Matrix System Summary page 1 …72 and K1 10283; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and…	Synthes (Usa)	2010	—
*	K100952	Modification to Synthes Matrix System Summary page 1 …83; the Medyssey Novel Spinal System K081153, K1 03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and…	Synthes Spine	2010	Class I
*	K061202	Revere Stabilization System Summary page 1 …03147, and K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623,…	Globus Medical, Inc.	2006	—
*	K081195	Revere Uniplanar Screws Summary page 1 …d K1 10284; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657,…	Globus Medical, Inc.	2008	—
*	K091782	Revere 6.35 Stabilization System Summary page 1 …84; the Synthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657,…	Globus Medical, Inc.	2009	—
*	K093294	Revere Stabilization System Summary page 1 …ynthes Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657,…	Globus Medical, Inc.	2010	—
*	K100788	Cocr Rods Summary page 1 …Matrix Spine System K092929, K1 00634 and K1 00952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K07194…	Globus Medical, Inc.	2010	—
*	K100623	Aesculap Implant Systems S4 Spinal System Summary page 1 …Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K071945, K062085 and K032219) Product Description: The Medyssey Co. Ltd., Cannulated Pedicle Scr…	Aesculap Implant Systems	2010	1
*	K090657	Modification to: S4 Spinal System Summary page 1 …Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K071945, K062085 and K032219) Product Description: The Medyssey Co. Ltd., Cannulated Pedicle Screws are i…	Aesculap Implant Systems	2009	—
*	K071945	S4 Spinal System Summary page 1 …K061202, K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K071945, K062085 and K032219) Product Description: The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with…	Aesculap Implant Systems	2007	—
*	K062085	S4 Spinal System Summary page 1 …K081195 K091782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K071945, K062085 and K032219) Product Description: The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with…	Aesculap	2007	—
*	K032219	Revolution Spinal Fixation System Summary page 1 …1782, K093294 and K100788; and the Aesculap S4 MIS Cannulated Pedicle Screw System (K1 00623, K090657, K071945, K062085 and K032219) Product Description: The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their re…	Spinal Innovations, Inc.	2003	—

Also cleared against K103272: 3 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131878	Lliad, Kora, Zenius Pedicle Screw System	Medyssey USA, Inc.	2013	8
K171526	Zenius™, lliad™ and Kora™ Spinal Fixation Systems	Medyssey USA, Inc.	2017	2
K232218	Zenius™ Spinal System	Medyssey USA, Inc.	2023	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
15 of the 108 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K131878 (Medyssey USA, Inc., 2013) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K103272.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121670 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121670: Medyssey Cannulated Pedicle Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121670

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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