510(k) · Decided

Decided

OP Spine System

K120291510(k) TraditionalDecided Apr 16, 201276-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

OrthoPediatrics Corp. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Cleared on Apr 16, 2012 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) and 13 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1999. 138 later devices descend from it.

Decided: Apr 16, 2012
Review: 76 days
Class: Class II
Product code: OSH
Recalls: None
Predicates: 14

Its longest line of descent runs back 5 generations to K990745 (1999). 50 ancestors in all, the oldest K781443 (1978). 138 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
3 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
2 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
1 generation backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
This deviceK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
Descendant · cites it directly · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
Descendant · 2 generations on · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
Descendant · 3 generations on · 78 of its ownK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
Descendant · 3 generations on · 73 of its ownK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
Descendant · 4 generations on · 61 of its ownK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled

Showing 5 of 138 descendants. See all descendants

Descendants cleared per year

2012high 17 (2023) · low 2 (2012)2026

Most influential descendants

Showing 5 of 138 · See all

K121630Range Spinal SystemK2m, Inc. · 2012 · cites it directly127descendants
K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · 2 generations on81descendants
K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · 3 generations on78descendants
K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · 3 generations on73descendants
K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc. · 2017 · 4 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
−4	K992739	Click'x	Synthes Spine	2000	1
−3	K052123	Synthes Pangea System	Synthes (Usa)	2005	—
−2	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
−1	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
0 (this device)	K120291	OP Spine System	OrthoPediatrics Corp.	2012	—
+1	K121630	Range Spinal System	K2m, Inc.	2012	—
+2	K130932	Firebird Spinal Fixation System	Orthofix, Inc.	2013	1
+3	K151488	Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System	Orthofix, Inc.	2015	1
+3	K153428	Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System	Orthofix, Inc.	2016	1
+4	K171082	Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS…	Orthofix, Inc.	2017	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1994	1	0
1995	3	0
1996	5	0
1997	2	0
1998	6	0
1999	1	0
2000	7	0
2001	5	0
2002	3	0
2003	5	0
2004	1	0
2005	1	0
2006	2	0
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2013	8	0
2014	6	0
2015	9	0
2016	8	0
2017	7	0
2018	10	0
2019	6	0
2020	6	0
2021	8	0
2022	14	0
2023	17	0
2024	15	0
2025	9	0
2026	13	0

FIG. 1 — Lineage of K120291, 1999–2026Source: 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 OSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (14)

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
*	K091445	CD Horizon Spinal System Summary page 1 …d to be used with autograft and/or allograft. MATERIALS: Medical grade titanium alloy ) Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I…	Medtronic Sofamor Danek	2010	—
*	K994121	Small Stature Uss Summary page 1 …lograft. MATERIALS: Medical grade titanium alloy ) Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) D…	Synthes (Usa)	2000	—
*	K082572	Uss Iliosacral, Uss Polyaxial Summary page 1 …MATERIALS: Medical grade titanium alloy ) Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spin…	Synthes Spine	2008	—
*	K011437	Synergy 4.0 MM, 4.5 MM VLS Screws Summary page 1 …ium alloy ) Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623…	Interpore Cross Intl.	2001	—
*	K081952	Synergy Spinal System (6.35 Polaris) Summary page 1 …) Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182…	Biomet Spine	2008	—
*	K980485	Isola Spinal System Summary page 1 …ium-molybdenum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 === Page 2…	Acromed Corp.	1998	—
*	K022285	Modification to Isola Spinal System Summary page 1 …denum PREDICATE DEVICES: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHN…	Depuyacromed	2002	—
*	K051971	Optima Spinal System Summary page 1 …S: Medtronic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS…	U&I Corp.	2005	—
*	K031585	U&I, Optima, Spinal System Summary page 1 …nic CD Horizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFOR…	U&I Corp., America	2003	5
*	K024096	Optima, Spinal System Summary page 1 …rizon {K091445) Synthes USS Spinal System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFORMANCE DAT…	U&I Corp., America	2003	3
*	K030383	Modification to Moss Miami Spinal System Polyaxial Screws Summary page 1 …l System (K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFORMANCE DATA: 120241 [)aga‘ "Z A2 The funda…	Depuyacromed	2003	—
*	K022623	5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) Summary page 1 …(K994121, K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFORMANCE DATA: 120241 [)aga‘ "Z A2 The fundamental sc…	Depuyacromed	2002	—
*	K011182	Modified Moss Miami 4.35MM Diameter Polyaxial Screws Summary page 1 …K082572) Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFORMANCE DATA: 120241 [)aga‘ "Z A2 The fundamental scientific…	Depuyacromed	2001	—
*	K982511	Depuy Motech Moss Miami Spinal Systems Summary page 1 …Biomet Synefgy VLS (K011437, K081952) DePuy Spine Isola (K980485, K022285) U&I Optima (K051971, K031585, K024096) DePuy Spine Moss Miami (K030383, K022623, K011182, K982511) 1-10 TECHNOLOGIC CHARACTERISTICS: PERFORMANCE DATA: 120241 [)aga‘ "Z A2 The fundamental scientific pfinciple…	Depuy, Inc.	1998	—

Also cleared against K091445: 26 other devices →

What descends from it? (138)

See all 138

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

Number	Device	Applicant	Decided	Descendants
K121630	Range Spinal System	K2m, Inc.	2012	127
K121250	OP Spine System	OrthoPediatrics Corp.	2012	18
K130655	Response Spine System	OrthoPediatrics Corp.	2013	17
K150600	Response 5.5/6.0 Spine System	OrthoPediatrics Corp.	2015	16

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 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
5 of the 50 ancestors have a recall of any class.
Of its descendants, K121630 (K2m, Inc., 2012) has gone furthest, with 127 descendants of its own.
26 other devices also cite its predicate K091445.

How does its category compare?

All OSH devices

OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OSH

1in 2016

2007high 14 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OSH

82in 2013

2007high 82 (2013) · low 76 (2012)2026

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

Recalls per year · OSH

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OSH

3in 2025

2007high 18 (2023) · low 0 (2007)2025

MAUDE reports naming product code OSH, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	1
2010	0	—	0	0
2011	0	—	0	1
2012	3	76	0	1
2013	14	82	0	2
2014	1	—	0	1
2015	0	—	0	3
2016	1	—	0	9
2017	0	—	1	4
2018	0	—	0	14
2019	0	—	0	12
2020	0	—	0	12
2021	0	—	0	2
2022	0	—	0	8
2023	0	—	0	18
2024	0	—	0	12
2025	0	—	0	3
2026	0	—	0	—

What is it indicated for?

The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

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/K120291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120291: OP Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120291

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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