510(k) · Decided
DecidedOP Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on Jun 19, 2012 as substantially equivalent to K120291 (OrthoPediatrics Corp., 2012) after a 55-day review. Its family tree reaches back 6 generations to 1999. 18 later devices descend from it.
- Decided
- Jun 19, 2012
- Review
- 55 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K990745 (1999). 51 ancestors in all, the oldest K781443 (1978). 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 4 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 3 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 2 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 1 generation backK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- This deviceK121250 OP Spine SystemOrthoPediatrics Corp. · 2012
- Descendant · cites it directly · 17 of its ownK130655 Response Spine SystemOrthoPediatrics Corp. · 2013
- Descendant · 2 generations on · 16 of its ownK150600 Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · Recalled
- Descendant · 3 generations on · 13 of its ownK181390 Response Spine System, Response 5.5/6.0 Spine System, Response…OrthoPediatrics Corp. · 2018
- Descendant · 4 generations on · 4 of its ownK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- Descendant · 3 generations on · 4 of its ownK193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™…OrthoPediatrics Corp. · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K130655Response Spine SystemOrthoPediatrics Corp. · 2013 · cites it directly17descendants
- K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · 2 generations on16descendants
- K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp. · 2018 · 3 generations on13descendants
- K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021 · 4 generations on4descendants
- K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −5 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −4 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −3 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −1 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| 0 (this device) | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| +1 | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | — |
| +2 | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | 3 |
| +3 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine… | OrthoPediatrics Corp. | 2018 | — |
| +4 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| +3 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0… | OrthoPediatrics Corp. | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K120291 | OP Spine SystemSummary page 1…intended to be used with autograft and/or allograft. MATERIALS: Medical grade titanium alloy Medical grade cobalt-chromium-molybdenum PREDICATE DEVICES: OP Spine System [K120291] TECHNOLOGIC The fundamental scientific principles and technological CHARACTERISTICS: characteristics, including the intended use… | 2012 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130655 | Response Spine System | 2013 | 17 |
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 51 ancestors have a recall of any class.
- Of its descendants, K130655 (OrthoPediatrics Corp., 2013) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K120291.
How does its category compare?
All OSH devicesOSH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OSH
82in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSH
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSH
3in 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 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/K121250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121250: OP 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/K121250
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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