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 May 18, 2012 as substantially equivalent to K963045 (Synthes (Usa), 1997) and 13 other predicates after a 52-day review. Its family tree reaches back 14 generations to 1985. 1 of the 181 devices in its family, counting itself, has a Class I recall.
- Decided
- May 18, 2012
- Review
- 52 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 14 generations to K853033 (1985). 180 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 181 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
- This deviceK120928 Synthes Matrix SystemSynthes Spine · 2012
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
- This deviceK120928 Synthes Matrix SystemSynthes Spine · 2012
Class I recalls in this family
- K100952 Modification to Synthes Matrix Systemdirect predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
| −1 | K110216 | Expedium System, Viper System | Depuy Spine, Inc. | 2011 | — |
| 0 (this device) | K120928 | Synthes Matrix System | Synthes Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 14 | 0 |
| 2002 | 10 | 0 |
| 2003 | 11 | 0 |
| 2004 | 21 | 0 |
| 2005 | 20 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 1 |
| 2011 | 4 | 0 |
| 2012 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…Orthopaedic and Rehabilitation Devices Panel ___________Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes UISS, K1 11358 Synthes Click'X, K(992739 Synthes MIRS, K11304… | 1997 |
| * | K111358 | Synthes UssSummary page 1…ation Devices Panel ___________Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes UISS, K1 11358 Synthes Click'X, K(992739 Synthes MIRS, K113044 Synthes Cli… | 2011 |
| * | K992739 | Click'xSummary page 1…Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes UISS, K1 11358 Synthes Click'X, K(992739 Synthes MIRS, K113044 Synthes Click'X, K(031175 Synthes UISS, K1 13149… | 2000 |
| * | K113044 | Synthes MirsSummary page 1…dicates: Synthes UISS, K963045 Synthes UISS, K1 11358 Synthes Click'X, K(992739 Synthes MIRS, K113044 Synthes Click'X, K(031175 Synthes UISS, K1 13149 Synthes UI… | 2011 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Synthes UISS, K1 11358 Synthes Click'X, K(992739 Synthes MIRS, K113044 Synthes Click'X, K(031175 Synthes UISS, K1 13149 Synthes UISS Illiosacral and Polyaxial, DePuy Expediumn (last cl… | 2003 |
| * | K113149 | Synthes Uss ConnectorsSummary page 1…Synthes Click'X, K(992739 Synthes MIRS, K113044 Synthes Click'X, K(031175 Synthes UISS, K1 13149 Synthes UISS Illiosacral and Polyaxial, DePuy Expediumn (last cleared as… | 2012 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…5 Synthes UISS, K1 13149 Synthes UISS Illiosacral and Polyaxial, DePuy Expediumn (last cleared as K082572 K110216) Synthes Matrix System, K092929 Stryker Xia (l… | 2008 |
| * | K110216 | Expedium System, Viper SystemSummary page 1…Synthes UISS Illiosacral and Polyaxial, DePuy Expediumn (last cleared as K082572 K110216) Synthes Matrix System, K092929 Stryker Xia (last cleared as… | 2011 |
| * | K092929 | Synthes Matrix SystemSummary page 1…al, DePuy Expediumn (last cleared as K082572 K110216) Synthes Matrix System, K092929 Stryker Xia (last cleared as Synthes Matrix System, K093668 K(092605)… | 2009 |
| * | K092605 | Xia 4.5 Spinal SystemSummary page 1…Synthes Matrix System, K092929 Stryker Xia (last cleared as Synthes Matrix System, K093668 K(092605) Synthes Matrix System, K100952 Medtronic CID Horizon (last cleared ___________Syn… | 2009 |
| * | K093668 | Synthes Matrix Mis RodsSummary page 1…K110216) Synthes Matrix System, K092929 Stryker Xia (last cleared as Synthes Matrix System, K093668 K(092605) Synthes Matrix System, K100952 Medtronic CID Horizon (last cleare… | 2010 |
| * | K113529 | CD Horizon Voyager Spinal SystemSummary page 1…Synthes Matrix System, K100952 Medtronic CID Horizon (last cleared ___________Synthes Matrix System, K 100634 as K1 13529) Device This is an addition to Synthes' existing non-cervical spinal fixation devices Description:… | 2012 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 1…Stryker Xia (last cleared as Synthes Matrix System, K093668 K(092605) Synthes Matrix System, K100952 Medtronic CID Horizon (last cleared ___________Synthes Matrix System, K 100634 as K1 13… | 2010 |
| * | K100634 | Synthes Matrix SystemSummary page 1…K(092605) Synthes Matrix System, K100952 Medtronic CID Horizon (last cleared ___________Synthes Matrix System, K 100634 as K1 13529) Device This is an addition to Synthes' existing non-cervical spinal fixation device… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 23 of the 180 ancestors have a recall of any class; 1 has a Class I recall.
- 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 (470 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 3.5mm 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 3.5mm 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.
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/K120928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120928: Synthes Matrix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120928
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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