510(k) · Cleared
ClearedResponse 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 May 8, 2013 as substantially equivalent to K120291 (OrthoPediatrics Corp., 2012) and 2 other predicates after a 57-day review. Its family tree reaches back 7 generations to 1999. 17 later devices descend from it.
- Decided
- May 8, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K990745 (1999). 52 ancestors in all, the oldest K781443 (1978). 17 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 4 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 3 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- 1 generation backK121250 OP Spine SystemOrthoPediatrics Corp. · 2012
- This deviceK130655 Response Spine SystemOrthoPediatrics Corp. · 2013
- Descendant · cites it directly · 16 of its ownK150600 Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · Recalled
- Descendant · 2 generations on · 13 of its ownK181390 Response Spine System, Response 5.5/6.0 Spine System, Response…OrthoPediatrics Corp. · 2018
- Descendant · 3 generations on · 4 of its ownK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- Descendant · 2 generations on · 4 of its ownK193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™…OrthoPediatrics Corp. · 2020
- Descendant · 3 generations on · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · cites it directly16descendants
- K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp. · 2018 · 2 generations on13descendants
- K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021 · 3 generations on4descendants
- K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2020 · 2 generations on4descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −4 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −3 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| −1 | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| 0 (this device) | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | — |
| +1 | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | 3 |
| +2 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine… | OrthoPediatrics Corp. | 2018 | — |
| +3 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| +2 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0… | OrthoPediatrics Corp. | 2020 | — |
| +3 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
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 |
|---|---|---|
| 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? (3)
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…Medical grade cobalt-chromium-molybdenum - ASTM Fl1537-08 PREDICATE DEVICES: OrthoPediatrics' OP Spine System (K1 20291 and K1 21250) Medtronic CD Horizon (K091445) 1-33 === Page 2… | 2012 |
| * | K121250 | OP Spine SystemSummary page 1…Medical grade cobalt-chromium-molybdenum - ASTM Fl1537-08 PREDICATE DEVICES: OrthoPediatrics' OP Spine System (K1 20291 and K1 21250) Medtronic CD Horizon (K091445) 1-33… | 2012 |
| * | K091445 | CD Horizon Spinal SystemSummary page 1…M Fl1537-08 PREDICATE DEVICES: OrthoPediatrics' OP Spine System (K1 20291 and K1 21250) Medtronic CD Horizon (K091445) 1-33… | 2010 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 52 ancestors have a recall of any class.
- Of its descendants, K150600 (OrthoPediatrics Corp., 2015) has gone furthest, with 16 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. 2013, 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 Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2ilium 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 as stated in the FDA summary.
https://510kreport.com/device/K130655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130655: Response 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/K130655
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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