510(k) · Cleared
ClearedRESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 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 Mar 24, 2020 as substantially equivalent to K181390 (OrthoPediatrics Corp., 2018) and 2 other predicates after a 137-day review. Its family tree reaches back 10 generations to 2004. 4 later devices descend from it.
- Decided
- Mar 24, 2020
- Review
- 137 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K040583 (2004). 114 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations between
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK141494 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™…OrthoPediatrics Corp. · 2020
- Descendant · cites it directly · 2 of its ownK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK223096 Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
- Descendant · cites it directly · 0 of its ownK222105 RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp. · 2023
Show all 10 generations
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK141494 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™…OrthoPediatrics Corp. · 2020
Most influential descendants
Showing 4 of 4 · See all- K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021 · cites it directly2descendants
- K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023 · 2 generations on1descendant
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 3 generations on0descendants
- K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −7 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −5 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −1 | K141494 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0… | OrthoPediatrics Corp. | 2020 | — |
| +1 | K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021 | — |
| +2 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | — |
| +3 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
| +1 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | OrthoPediatrics Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemSummary page 4…following devices: x Primary Predicate: o Response Spine System (Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System), K181390, OrthoPediatrics, Corp. x Additional Predicates: o CD HORIZON® Spinal System, K141494, Medtronic Sofamor D… | 2018 |
| * | K141494 | CD Horizon Spinal SystemSummary page 4…ne System, Response 4.5/5.0 Spine System), K181390, OrthoPediatrics, Corp. x Additional Predicates: o CD HORIZON® Spinal System, K141494, Medtronic Sofamor Danek USA, Incorporated o Response 5.5/6.0 Spine System, K150600, OrthoPediatr… | 2014 |
| * | K150600 | Response 5.5/6.0 Spine SystemSummary page 4…redicates: o CD HORIZON® Spinal System, K141494, Medtronic Sofamor Danek USA, Incorporated o Response 5.5/6.0 Spine System, K150600, OrthoPediatrics, Corp. K193100 - P… | 2015 |
What descends from it? (4)
2 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 16 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 15 of the 114 ancestors have a recall of any class.
- Of its descendants, K201420 (Republic Spine, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K181390.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 4.5/5.0 and 5.5/6.0 Spine Systems are 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…
Read the full statement (134 words)
The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems are 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 4.5/5.0 and 5.5/6.0 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The Response 4.5/5.0 and 5.5/6.0 Spine Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K193100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193100: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, 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/K193100
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