510(k) · Cleared
ClearedSynthes 6.0 Cocr and CPT TI-3 Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 5, 2011 as substantially equivalent to K052123 (Synthes (Usa), 2005) and 7 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1999. 1 of the 366 devices in its family, counting itself, has a Class I recall. 348 later devices descend from it.
- Decided
- Jan 5, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K990745 (1999). 17 ancestors in all, the oldest K926453 (1993). 348 later devices descend from it, 8 citing it directly. 1 of the 366 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 3 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 2 generations backK082914 ClampfixSynthes Spine · 2008
- 1 generation backK090605 ClampfixSynthes (Usa) · 2009
- This deviceK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
- Descendant · cites it directly · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 2 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 151 of its ownK111358 Synthes UssSynthes Spine · 2011
Showing 5 of 348 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 348 · See all- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · cites it directly172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 2 generations on158descendants
- K111358Synthes UssSynthes Spine · 2011 · cites it directly151descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −4 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −3 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −2 | K082914 | Clampfix | Synthes Spine | 2008 | — |
| −1 | K090605 | Clampfix | Synthes (Usa) | 2009 | — |
| 0 (this device) | K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | Synthes Spine | 2011 | — |
| +1 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +2 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +1 | K111358 | Synthes Uss | Synthes Spine | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K052123 | Synthes Pangea SystemSummary page 1…21 CFR 888.3050 - Spinal interlamninal fixation orthosis Product Code: KWP Synthes Pangea, K052123 Synthes Pangca Monoaxial, K052151 Synthes Matrix System, K092929… | 2005 |
| * | K052151 | Synthes Pangea Monoaxial SystemSummary page 1…orthosis Product Code: KWP Synthes Pangea, K052123 Synthes Pangca Monoaxial, K052151 Synthes Matrix System, K092929 Synthes Click'X, K992739 Predicate… | 2005 |
| * | K092929 | Synthes Matrix SystemSummary page 1…Synthes Pangea, K052123 Synthes Pangca Monoaxial, K052151 Synthes Matrix System, K092929 Synthes Click'X, K992739 Predicate Devices: Synthes Spine SmallI Stature Anterior Cerv… | 2009 |
| * | K992739 | Click'xSummary page 1…Synthes Pangca Monoaxial, K052151 Synthes Matrix System, K092929 Synthes Click'X, K992739 Predicate Devices: Synthes Spine SmallI Stature Anterior Cervical Vertebrae Plate Syst… | 2000 |
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 1…Synthes Click'X, K992739 Predicate Devices: Synthes Spine SmallI Stature Anterior Cervical Vertebrae Plate System, K971 883 Synthes USS Illiosacral and Polyaxial, K082572 Synthes USS, K(96304… | 1997 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…ne SmallI Stature Anterior Cervical Vertebrae Plate System, K971 883 Synthes USS Illiosacral and Polyaxial, K082572 Synthes USS, K(963045 _______________Synthes Clamp~ix, K(090605… | 2008 |
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…System, K971 883 Synthes USS Illiosacral and Polyaxial, K082572 Synthes USS, K(963045 _______________Synthes Clamp~ix, K(090605 The Syfithes CoCr ahd Cp Ti-3 Rods are a… | 1997 |
| * | K090605 | ClampfixSummary page 1…Synthes USS Illiosacral and Polyaxial, K082572 Synthes USS, K(963045 _______________Synthes Clamp~ix, K(090605 The Syfithes CoCr ahd Cp Ti-3 Rods are an addition to Synthes' exis… | 2009 |
What descends from it? (348)
See all 3488 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K113395 (Globus Medical, Inc., 2012) has gone furthest, with 260 descendants of its own.
- 20 other devices also cite its predicate K052123.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc…
Read the full statement (342 words)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed 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 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and tmansconnectors except Synthes 6.0 tur cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
Synthes USS
6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Glick'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5min Rod System: Matrix
5.0mm Rod System: USS Small Stature
Cervix
3.5mm Rod Systems: CerviFix, Axon, Synapse
4.0mm System: Synapse
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103287: Synthes 6.0 Cocr and CPT TI-3 Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103287
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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