510(k) · Cleared
ClearedSynthes Matrix System
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 Jul 1, 2010 as substantially equivalent to K963045 (Synthes (Usa), 1997) and 8 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1999. 2 of the 333 devices in its family, counting itself, have a Class I recall. 316 later devices descend from it.
- Decided
- Jul 1, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K990745 (1999). 16 ancestors in all, the oldest K963045 (1997). 316 later devices descend from it, 9 citing it directly. 2 of the 333 devices in this family, counting this one, have 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 backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- This deviceK100634 Synthes Matrix SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
- 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
- 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
Showing 5 of 316 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 316 · See all- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · cites it directly314descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 2 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 3 generations on158descendants
- K111358Synthes UssSynthes Spine · 2011 · cites it directly151descendants
- K113149Synthes Uss ConnectorsSynthes Spine · 2012 · cites it directly93descendants
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 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| 0 (this device) | K100634 | Synthes Matrix System | Synthes (Usa) | 2010 | — |
| +1 | K100952 | Modification to Synthes Matrix System | Synthes Spine | 2010 | Class I |
| +2 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +3 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +1 | K111358 | Synthes Uss | Synthes Spine | 2011 | — |
| +1 | K113149 | Synthes Uss Connectors | Synthes Spine | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 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? (9)
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 |
|---|---|---|---|
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Univeral Sacral System, K963045 Synthes Matrix System, K092929 Synthes Pangea System, K052 151… | 1997 |
| * | K092929 | Synthes Matrix SystemSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicate Devices: Synthes Univeral Sacral System, K963045 Synthes Matrix System, K092929 Synthes Pangea System, K052 151 Synthes Click'X Monoaxial, K031… | 2009 |
| * | K052151 | Synthes Pangea Monoaxial SystemSummary page 1…Synthes Univeral Sacral System, K963045 Synthes Matrix System, K092929 Synthes Pangea System, K052 151 Synthes Click'X Monoaxial, K031 175 Synthes Dual Opening UISS,… | 2005 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Synthes Matrix System, K092929 Synthes Pangea System, K052 151 Synthes Click'X Monoaxial, K031 175 Synthes Dual Opening UISS, K023675 Synthes UISS, K022949… | 2003 |
| * | K023675 | Synthes Cervifix/ AxonSummary page 1…Synthes Pangea System, K052 151 Synthes Click'X Monoaxial, K031 175 Synthes Dual Opening UISS, K023675 Synthes UISS, K022949 Synthes USS Ilioisacral and USS Polyaxial… | 2002 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…Synthes Click'X Monoaxial, K031 175 Synthes Dual Opening UISS, K023675 Synthes UISS, K022949 Synthes USS Ilioisacral and USS Polyaxial, K082572 Synthes Cerv… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…Synthes Dual Opening UISS, K023675 Synthes UISS, K022949 Synthes USS Ilioisacral and USS Polyaxial, K082572 Synthes Cervi Fix, KOO01864 Synthes Synapse System, K070573 Dev… | 2008 |
| * | K001864 | Synthes Cervifix System | 2000 |
| * | K070573 | Synapse SystemSummary page 1…Synthes USS Ilioisacral and USS Polyaxial, K082572 Synthes Cervi Fix, KOO01864 Synthes Synapse System, K070573 Device The Synthes Matrix System is an addition to Synthes' existing posterior Description:… | 2007 |
What descends from it? (316)
See all 3169 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100952 | Modification to Synthes Matrix System Class I | 2010 | 314 |
| K111358 | Synthes Uss | 2011 | 151 |
| K113149 | Synthes Uss Connectors | 2012 | 93 |
| K113044 | Synthes Mirs | 2011 | 93 |
| K120571 | Synthes Uss Connector | 2012 | 74 |
| K120838 | Synthes Matrix System | 2012 | 16 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
| K142460 | EXPEDIUM Spine System/Synapse System | 2014 | 0 |
| K120928 | Synthes Matrix System | 2012 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K100952 (Synthes Spine, 2010) has gone furthest, with 314 descendants of its own.
- 10 other devices also cite its predicate K963045.
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 UJSS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iliumn), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedlicle 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 (347 words)
The Synthes UJSS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iliumn), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedlicle 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), tumnor, 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 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 UISS 6.0 mm rod systems.
When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can he linked to the CerviFix 3.5 min and 4.0 mm Systems, respectively. When used with the 3.5/5.5 min 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.
SynthesUS
6.0 mm Rod Systems: USS Side-Opening, LISS Dual-Opening, US5 VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, LI55 Polyaxial, US5 Iliosacral, ClanpFfix
5.5 mm Rod System: Matrix
5.0 mm Rod System: UISS 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/K100634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100634: Synthes Matrix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100634
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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