510(k) · Cleared
Recalled · Class II · 2020Response 5.5/6.0 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 May 22, 2015 as substantially equivalent to K130655 (OrthoPediatrics Corp., 2013) and 2 other predicates after a 73-day review. Its family tree reaches back 8 generations to 1999. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- May 22, 2015
- Review
- 73 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 8 generations to K990745 (1999). 53 ancestors in all, the oldest K781443 (1978). 16 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 5 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 4 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- 2 generations backK121250 OP Spine SystemOrthoPediatrics Corp. · 2012
- 1 generation backK130655 Response Spine SystemOrthoPediatrics Corp. · 2013
- This deviceK150600 Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2015
- Descendant · cites it directly · 13 of its ownK181390 Response Spine System, Response 5.5/6.0 Spine System, Response…OrthoPediatrics Corp. · 2018
- Descendant · 2 generations on · 4 of its ownK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- Descendant · cites it directly · 4 of its ownK193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™…OrthoPediatrics Corp. · 2020
- Descendant · 2 generations on · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp. · 2018 · cites it directly13descendants
- K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021 · 2 generations on4descendants
- K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 2020 · cites it directly4descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · 2 generations on2descendants
- K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −5 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −4 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| −2 | K121250 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| −1 | K130655 | Response Spine System | OrthoPediatrics Corp. | 2013 | — |
| 0 (this device) | K150600 | Response 5.5/6.0 Spine System | OrthoPediatrics Corp. | 2015 | — |
| +1 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine… | OrthoPediatrics Corp. | 2018 | — |
| +2 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| +1 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0… | OrthoPediatrics Corp. | 2020 | — |
| +2 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
| +3 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | — |
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 | 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 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? (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 |
|---|---|---|---|
| * | K130655 | Response Spine SystemSummary page 4…Classification Class III; 21 CFR 888.3070 and 21 CFR 888.3050 Product Codes NKB, OSH, MNH, MNI, KWP III. Predicates K130655 – OrthoPediatrics Response Spine – (PRIMARY) K091445 – Medtronic CD Horizon Spine System… | 2013 |
| * | K091445 | CD Horizon Spinal SystemSummary page 4…Product Codes NKB, OSH, MNH, MNI, KWP III. Predicates K130655 – OrthoPediatrics Response Spine – (PRIMARY) K091445 – Medtronic CD Horizon Spine System K120291 – OrthoPediatrics OP Spine System… | 2010 |
| * | K120291 | OP Spine SystemSummary page 4…K130655 – OrthoPediatrics Response Spine – (PRIMARY) K091445 – Medtronic CD Horizon Spine System K120291 – OrthoPediatrics OP Spine System None of the above predicates have been subject to a… | 2012 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2020 | Class II | Z-2742-2020 | Under Investigation by firm | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device |
| Aug 3, 2017 | Class II | Z-0597-2018 | Employee error | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. |
| Nov 10, 2015 | Class II | Z-0622-2016 | Process change control | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K181390 (OrthoPediatrics Corp., 2018) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K130655.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical 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 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical 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 5.5/6.0 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5/6.0 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/K150600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150600: Response 5.5/6.0 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/K150600
Report an extraction error
Are you the manufacturer?
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