510(k) · Cleared
ClearedSynthes Uss
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 Nov 18, 2011 as substantially equivalent to K992739 (Synthes Spine, 2000) and 6 other predicates after a 186-day review. Its family tree reaches back 6 generations to 1999. 1 of the 176 devices in its family, counting itself, has a Class I recall. 151 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 186 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K990745 (1999). 24 ancestors in all, the oldest K926453 (1993). 151 later devices descend from it, 6 citing it directly. 1 of the 176 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 4 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 3 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 2 generations backK100634 Synthes Matrix SystemSynthes (Usa) · 2010
- 1 generation backK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
- This deviceK111358 Synthes UssSynthes Spine · 2011
- Descendant · cites it directly · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · 2 generations on · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 2 generations on · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix Systemdirect predicate · 2010
Most influential descendants
Showing 5 of 151 · See all- K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · cites it directly77descendants
- K120571Synthes Uss ConnectorSynthes Spine · 2012 · cites it directly74descendants
- K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 2 generations on67descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 2 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −5 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −4 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −3 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −2 | K100634 | Synthes Matrix System | Synthes (Usa) | 2010 | — |
| −1 | K100952 | Modification to Synthes Matrix System | Synthes Spine | 2010 | Class I |
| 0 (this device) | K111358 | Synthes Uss | Synthes Spine | 2011 | — |
| +1 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +2 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +2 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 14 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 22 | 0 |
| 2024 | 19 | 0 |
| 2025 | 19 | 0 |
| 2026 | 16 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K983045 | FDA’s K983045 is Amielle Our OCR of the scanned summary read K983045, FDA’s number for Amielle (Owen Mumford USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes USS”. Kept off the family tree. Summary page 1…ion orthosis 21 CFR 888.3070-Pedicle screw spinal system, Class lli Orthopaedic and Rehabilitation Devices Panel Proeduct Caode: NKB, MNH, MNI, KWQ, KWP Synthes USS, K983045 Synthes Click’X, K982739 Synthes Click’X, K031175 Synthes USS llliosacral and Polyaxial, K082572 Synthes Matrix System, K0929… | 1998 |
| * | K992739 | Click'x Our OCR of the scanned summary read K982739, FDA’s number for Gynex Electrodes (Gynex Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Click’X”. | 2000 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…ystem, Class lli Orthopaedic and Rehabilitation Devices Panel Proeduct Caode: NKB, MNH, MNI, KWQ, KWP Synthes USS, K983045 Synthes Click’X, K982739 Synthes Click’X, K031175 Synthes USS llliosacral and Polyaxial, K082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix S… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…Devices Panel Proeduct Caode: NKB, MNH, MNI, KWQ, KWP Synthes USS, K983045 Synthes Click’X, K982739 Synthes Click’X, K031175 Synthes USS llliosacral and Polyaxial, K082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100852 Synthes 6.0 CoCr and CP Ti-3 Rod… | 2008 |
| * | K092929 | Synthes Matrix SystemSummary page 1…NKB, MNH, MNI, KWQ, KWP Synthes USS, K983045 Synthes Click’X, K982739 Synthes Click’X, K031175 Synthes USS llliosacral and Polyaxial, K082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100852 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 The Synthes USS is a… | 2009 |
| * | K100634 | Synthes Matrix SystemSummary page 1…USS, K983045 Synthes Click’X, K982739 Synthes Click’X, K031175 Synthes USS llliosacral and Polyaxial, K082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100852 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 The Synthes USS is an addition to Synthes’ existing… | 2010 |
| * | K100952 | Modification to Synthes Matrix System Our OCR of the scanned summary read K100852, FDA’s number for Stryker Switchpoint Infinity 3 Control System, Model… (Stryker Communications). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Matrix System”. | 2010 |
| * | K103287 | Synthes 6.0 Cocr and CPT TI-3 RodsSummary page 1…SS llliosacral and Polyaxial, K082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100852 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 The Synthes USS is an addition to Synthes’ existing non-cervical spinal fixation devices intended for posterior pedicle screw fi… | 2011 |
What descends from it? (151)
See all 1516 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · Direct predicate · ◆ on the line of descent in 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 1.6 years on median.
- 4 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143684 (Nu Vasive, Incorporated, 2015) has gone furthest, with 77 descendants of its own.
- 20 other devices also cite its predicate K992739.
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-LS). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes smail 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 (382 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-LS). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes smail 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 Smail Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm red systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
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 transconnectors except Synthes 6.0mm 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, Click'X, Click’X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
• 5.5mm Rod System: Matrix
• 5.0mm Rod System: USS Small Stature
CerviFix
• 3.5mm Rod Systems: CerviFix, Axon, Synapse
• 4.0mm Rod System: Synapse
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/K111358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111358: Synthes Uss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111358
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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