510(k) · Cleared
Recalled · Class I · 2014Modification to Synthes Matrix System
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 Aug 5, 2010 as substantially equivalent to K092929 (Synthes (Usa), 2009) and 6 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1999. 2 of the 332 devices in its family, counting itself, have a Class I recall. 314 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 5, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2 (1 Class I)
- Predicates
- 7
Its longest line of descent runs back 5 generations to K990745 (1999). 17 ancestors in all, the oldest K963045 (1997). 314 later devices descend from it, 14 citing it directly. 2 of the 332 devices in this family, counting this one, have 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 backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 1 generation backK100634 Synthes Matrix SystemSynthes (Usa) · 2010
- This deviceK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010
- 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
- Descendant · cites it directly · 93 of its ownK113149 Synthes Uss ConnectorsSynthes Spine · 2012
- Descendant · cites it directly · 93 of its ownK113044 Synthes MirsSynthes Spine · 2011 · Recalled
Showing 5 of 314 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 314 · See all- 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
- K113149Synthes Uss ConnectorsSynthes Spine · 2012 · cites it directly93descendants
- K113044Synthes MirsSynthes Spine · 2011 · cites it directly93descendants
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 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −1 | K100634 | Synthes Matrix System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K100952 | Modification to Synthes Matrix System | Synthes Spine | 2010 | — |
| +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 | — |
| +1 | K113149 | Synthes Uss Connectors | Synthes Spine | 2012 | — |
| +1 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 9 | 0 |
| 2017 | 21 | 0 |
| 2018 | 15 | 0 |
| 2019 | 19 | 0 |
| 2020 | 21 | 0 |
| 2021 | 20 | 1 |
| 2022 | 25 | 0 |
| 2023 | 37 | 0 |
| 2024 | 41 | 0 |
| 2025 | 38 | 0 |
| 2026 | 35 | 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.
2 devices in this family have 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? (7)
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 |
|---|---|---|---|
| * | K092929 | Synthes Matrix SystemSummary page 1…opatedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Matrix System, K092929, K 100634 Synthes USS, K963045, K082572 Synthes Click'X, K99273… | 2009 |
| * | K100634 | Synthes Matrix System Cleared while this submission was under review Summary page 1…and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Matrix System, K092929, K 100634 Synthes USS, K963045, K082572 Synthes Click'X, K992739… | 2010 |
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Matrix System, K092929, K 100634 Synthes USS, K963045, K082572 Synthes Click'X, K992739 Synthes Pangea, K052 123… | 1997 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Matrix System, K092929, K 100634 Synthes USS, K963045, K082572 Synthes Click'X, K992739 Synthes Pangea, K052 123… | 2008 |
| * | K992739 | Click'xSummary page 1…: Synthes Matrix System, K092929, K 100634 Synthes USS, K963045, K082572 Synthes Click'X, K992739 Synthes Pangea, K052 123 Synthes USS VAS, K0025 17 Device Desc… | 2000 |
| * | K052123 | Synthes Pangea SystemSummary page 1…Synthes USS, K963045, K082572 Synthes Click'X, K992739 Synthes Pangea, K052 123 Synthes USS VAS, K0025 17 Device Description: The Synthes Matrix System is an addi… | 2005 |
| * | K002517 | Uss VasSummary page 1…572 Synthes Click'X, K992739 Synthes Pangea, K052 123 Synthes USS VAS, K0025 17 Device Description: The Synthes Matrix System is an addition to Synthes' existing posterior… | 2000 |
What descends from it? (314)
See all 31414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124058 | Creo Stabilization System | 2013 | 172 |
| K111358 | Synthes Uss | 2011 | 151 |
| K113149 | Synthes Uss Connectors | 2012 | 93 |
| K113044 | Synthes Mirs | 2011 | 93 |
| K120571 | Synthes Uss Connector | 2012 | 74 |
| K121115 | M.U.S.T Pedicle Screw System | 2012 | 43 |
| K141988 | M.U.S.T Pedicle Screw System | 2014 | 26 |
| K141044 | M.U.S.T. Extension | 2014 | 16 |
| K120838 | Synthes Matrix System | 2012 | 16 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2014 | Class I | Z-0226-2015 | Process control | Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to… |
| Mar 11, 2011 | Not classified | Z-3207-2011 | Labeling Change Control | Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant… |
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 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K124058 (Globus Medical, Inc., 2013) has gone furthest, with 172 descendants of its own.
- 11 other devices also cite its predicate K092929.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 (TI-52/ilium), posterior hook fixation (TI-L-5), 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 (348 words)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-52/ilium), posterior hook fixation (TI-L-5), 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 lordlosis, 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 pedlicle screw construct.
When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS56.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.
Synthes USS
6.0 mm 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, Clamp Fix
5.5 mm Rod System: Matrix
5.0 mm Rod System: USS Small Stature
CerviFix
3.5 mm Rod Systems: CerviFix, Axon, Synapse
4.0 mm Rod System: Synapse
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100952: Modification to Synthes Matrix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100952
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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