510(k) · Cleared
ClearedSynthes 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 Jul 31, 2012 as substantially equivalent to K963045 (Synthes (Usa), 1997) and 12 other predicates after a 133-day review. Its family tree reaches back 10 generations to 2004. 1 of the 211 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Jul 31, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 10 generations to K040583 (2004). 194 ancestors in all, the oldest K781443 (1978). 16 later devices descend from it, 10 citing it directly. 1 of the 211 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations between
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- This deviceK120838 Synthes Matrix SystemSynthes Spine · 2012
- Descendant · cites it directly · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
- Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · cites it directly · 2 of its ownK170266 Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · cites it directly · 1 of its ownK181821 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018
Show all 10 generations
- Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 1 generation backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- This deviceK120838 Synthes Matrix SystemSynthes Spine · 2012
Showing 5 of 16 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 16 · See all- K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · cites it directly4descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
- K170266Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017 · cites it directly2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
- K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −7 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −5 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −1 | K113529 | CD Horizon Voyager Spinal System | Medtronic Sofamor Danek | 2012 | — |
| 0 (this device) | K120838 | Synthes Matrix System | Synthes Spine | 2012 | — |
| +1 | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
| +2 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +1 | K170266 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017 | — |
| +3 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +1 | K181821 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 12 | 0 |
| 2003 | 14 | 0 |
| 2004 | 18 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 1 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (14)
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 |
|---|---|---|---|
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…Class Ill Orthopaedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Medtronic CD Horizon, K1 13529 Synthes Click'X, K992739 EBI/Biomet Polaris, Ki… | 1997 |
| * | K113529 | CD Horizon Voyager Spinal SystemSummary page 1…nd Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Medtronic CD Horizon, K1 13529 Synthes Click'X, K992739 EBI/Biomet Polaris, Kil1957 Synthes Click'X,… | 2012 |
| * | K992739 | Click'xSummary page 1…oduct Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Medtronic CD Horizon, K1 13529 Synthes Click'X, K992739 EBI/Biomet Polaris, Kil1957 Synthes Click'X, K031175 Aesculap S4, K1 12551… | 2000 |
| Kept off the family tree | K011957 | FDA’s K011957 is Ivent 201 Portable Ventilator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Medtronic CD Horizon, K1 13529 Synthes Click'X, K992739 EBI/Biomet Polaris, Kil1957 Synthes Click'X, K031175 Aesculap S4, K1 12551 Synthes USS Illiosacral and Synthes USS, K1 11358… | 2003 |
| * | K112551 | S4 Spinal SystemSummary page 1…13529 Synthes Click'X, K992739 EBI/Biomet Polaris, Kil1957 Synthes Click'X, K031175 Aesculap S4, K1 12551 Synthes USS Illiosacral and Synthes USS, K1 11358 Polyaxial, K082572… | 2011 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…Click'X, K031175 Aesculap S4, K1 12551 Synthes USS Illiosacral and Synthes USS, K1 11358 Polyaxial, K082572 Synthes MI RS, K1 13044 Synthes Matrix System, K092929 Synthes UISS, K113149… | 2008 |
| * | K111358 | Synthes UssSummary page 1…ris, Kil1957 Synthes Click'X, K031175 Aesculap S4, K1 12551 Synthes USS Illiosacral and Synthes USS, K1 11358 Polyaxial, K082572 Synthes MI RS, K1 13044 Synthes Matrix Syste… | 2011 |
| * | K092929 | Synthes Matrix SystemSummary page 1…al and Synthes USS, K1 11358 Polyaxial, K082572 Synthes MI RS, K1 13044 Synthes Matrix System, K092929 Synthes UISS, K113149 Synthes Matrix System, K093668 Synthes Matrix System,… | 2009 |
| * | K113044 | Synthes MirsSummary page 1…, K1 12551 Synthes USS Illiosacral and Synthes USS, K1 11358 Polyaxial, K082572 Synthes MI RS, K1 13044 Synthes Matrix System, K092929 Synthes UISS, K113149 Synthes Matrix System,… | 2011 |
| * | K093668 | Synthes Matrix Mis RodsSummary page 1…Synthes MI RS, K1 13044 Synthes Matrix System, K092929 Synthes UISS, K113149 Synthes Matrix System, K093668 Synthes Matrix System, K100952 ___________Synthes Matrix System, K1 00634 Device… | 2010 |
| * | K113149 | Synthes Uss ConnectorsSummary page 1…K1 11358 Polyaxial, K082572 Synthes MI RS, K1 13044 Synthes Matrix System, K092929 Synthes UISS, K113149 Synthes Matrix System, K093668 Synthes Matrix System, K100952 ___________Synth… | 2012 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 1…Synthes Matrix System, K092929 Synthes UISS, K113149 Synthes Matrix System, K093668 Synthes Matrix System, K100952 ___________Synthes Matrix System, K1 00634 Device This is an addition to Synthes' existing non-cer… | 2010 |
| * | K100634 | Synthes Matrix SystemSummary page 1…SS, K113149 Synthes Matrix System, K093668 Synthes Matrix System, K100952 ___________Synthes Matrix System, K1 00634 Device This is an addition to Synthes' existing non-cervical spinal fixation Description: devices int… | 2010 |
What descends from it? (16)
See all 1610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151704 | Diplomat® Spinal System | 2016 | 4 |
| K170266 | Palisade™ Pedicular Fixation System | 2017 | 2 |
| K181821 | MOSS VRS Spinal System | 2018 | 1 |
| K170255 | Threshold™ V2 Pedicular Fixation System | 2017 | 1 |
| K170251 | Threshold™ Pedicular Fixation System | 2017 | 1 |
| K170268 | Fortress™ Pedicular Fixation System | 2017 | 1 |
| K153404 | Zavation Spinal System | 2016 | 1 |
| K203607 | MOSS VRS Spinal System | 2021 | 0 |
| K172107 | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™… | 2017 | 0 |
| K141850 | Flospine Pedicle Screw System | 2014 | 0 |
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 · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 25 of the 194 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K151704 (Signus Medizintechnik GmbH, 2016) has gone furthest, with 4 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. 2012, 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 (489 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 mm/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 mm/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 mm/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 5.5 mm/6.0 mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5 mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0 mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors; except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 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, ClampFix
5.5 mm Rod System: Matrix, MIRS
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/K120838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120838: 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/K120838
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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