510(k) · Cleared
ClearedClampfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 6, 2009 as substantially equivalent to K010658 (Synthes (Usa), 2001) and 4 other predicates after a 245-day review. Its family tree reaches back 4 generations to 1999. 1 of the 360 devices in its family, counting itself, has a Class I recall. 349 later devices descend from it.
- Decided
- Nov 6, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K990745 (1999). 10 ancestors in all, the oldest K963045 (1997). 349 later devices descend from it, 1 citing it directly. 1 of the 360 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 3 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 2 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 1 generation backK082914 ClampfixSynthes Spine · 2008
- This deviceK090605 ClampfixSynthes (Usa) · 2009
- Descendant · cites it directly · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
- Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 2 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
Showing 5 of 349 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 349 · See all- K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · cites it directly348descendants
- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 2 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 3 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −3 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −2 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −1 | K082914 | Clampfix | Synthes Spine | 2008 | — |
| 0 (this device) | K090605 | Clampfix | Synthes (Usa) | 2009 | — |
| +1 | K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | Synthes Spine | 2011 | — |
| +2 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +3 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +2 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +3 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 11 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 15 | 0 |
| 2016 | 10 | 0 |
| 2017 | 21 | 0 |
| 2018 | 21 | 0 |
| 2019 | 20 | 0 |
| 2020 | 22 | 0 |
| 2021 | 18 | 1 |
| 2022 | 26 | 0 |
| 2023 | 43 | 0 |
| 2024 | 48 | 0 |
| 2025 | 41 | 0 |
| 2026 | 37 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K010658 | Modified Uss Fracture SystemSummary page 1…rthopaedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes USS Fracture (K0 10658) Synthes Universal Sacral System (K963045) Synthes Click'X (K99… | 2001 |
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes USS Fracture (K0 10658) Synthes Universal Sacral System (K963045) Synthes Click'X (K992739) Synthes ClampFix (K082914)… | 1997 |
| * | K992739 | Click'xSummary page 1…Synthes USS Fracture (K0 10658) Synthes Universal Sacral System (K963045) Synthes Click'X (K992739) Synthes ClampFix (K082914) Synthes USS (K022949) Device… | 2000 |
| * | K082914 | ClampfixSummary page 1…Synthes Universal Sacral System (K963045) Synthes Click'X (K992739) Synthes ClampFix (K082914) Synthes USS (K022949) Device The Synthes ClampFix System is an additi… | 2008 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…045) Synthes Click'X (K992739) Synthes ClampFix (K082914) Synthes USS (K022949) Device The Synthes ClampFix System is an addition to Synthes' existing posterior Description:… | 2003 |
What descends from it? (349)
See all 3491 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | 2011 | 348 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K103287 (Synthes Spine, 2011) has gone furthest, with 348 descendants of its own.
- 4 other devices also cite its predicate K010658.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS fliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (TI-S2/ilium), a posterior hook fixation system (TI-L5), or as an…
Read the full statement (311 words)
The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS fliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (TI-S2/ilium), a posterior hook fixation system (TI-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confimed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS [liosacral, and ClampFix) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes ISS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS fliosacral, and ClampFix).
In addition, Synthes 0SS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS [liosacral, and ClampFix) can be interchanged with all USS 6.0 mm rods and transconnectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090605: Clampfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090605
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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