510(k) · Cleared
ClearedResponse 5.5 Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 23, 2016 as substantially equivalent to K150600 (OrthoPediatrics Corp., 2015) and 1 other predicate after a 33-day review. Its family tree reaches back 9 generations to 1999. 1 later device descends from it.
- Decided
- Mar 23, 2016
- Review
- 33 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K990745 (1999). 54 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK121250 OP Spine SystemOrthoPediatrics Corp. · 2012
- 2 generations backK130655 Response Spine SystemOrthoPediatrics Corp. · 2013
- 1 generation backK150600 Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · Recalled
- This deviceK160466 Response 5.5 Spine SystemOrthoPediatrics Corp. · 2016
- Descendant · cites it directly · 0 of its ownK162576 FORTEZZA Spinal Stabilization SystemOsso Surgical · 2016
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 backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 6 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 5 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 4 generations backK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- 3 generations backK121250 OP Spine SystemOrthoPediatrics Corp. · 2012
- 2 generations backK130655 Response Spine SystemOrthoPediatrics Corp. · 2013
- 1 generation backK150600 Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015 · Recalled
- This deviceK160466 Response 5.5 Spine SystemOrthoPediatrics Corp. · 2016
Most influential descendants
Showing 1 of 1 · See all- K162576FORTEZZA Spinal Stabilization SystemOsso Surgical · 2016 · cites it directly0descendants
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 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −6 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −5 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −4 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| −3 | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| −2 | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | — |
| −1 | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | 3 |
| 0 (this device) | K160466 | Response 5.5 Spine System | OrthoPediatrics Corp. | 2016 | — |
| +1 | K162576 | FORTEZZA Spinal Stabilization System | Osso Surgical | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 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 NKB? 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K150600 | Response 5.5/6.0 Spine SystemSummary page 4…3050) Classification Class III; 21 CFR 888.3070 and 21 CFR 888.3050 Product Codes NKB, OSH, MNH, MNI, KWP III. Predicates K150600 – OrthoPediatrics Response 5.5/6.0 Spine (PRIMARY)… | 2015 |
| * | K130655 | Response Spine SystemSummary page 4…K150600 – OrthoPediatrics Response 5.5/6.0 Spine (PRIMARY) K130655 – OrthoPediatrics Response 5.5 Spine System (ADDITIONAL)… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162576 | FORTEZZA Spinal Stabilization System | 2016 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 54 ancestors have a recall of any class.
- Of its descendants, K162576 (Osso Surgical, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150600.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 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 Response 5.5 Spine System is intended for immobilization and stabilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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…
Read the full statement (123 words)
The Response 5.5 Spine System is intended for immobilization and stabilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160466: Response 5.5 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/K160466
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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