510(k) · Cleared
ClearedSynthes Uss Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 1, 2012 as substantially equivalent to K962608 (Synthes (Usa), 1996) and 8 other predicates after a 100-day review. Its family tree reaches back 6 generations to 1999. 1 of the 119 devices in its family, counting itself, has a Class I recall. 93 later devices descend from it.
- Decided
- Feb 1, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K990745 (1999). 25 ancestors in all, the oldest K926453 (1993). 93 later devices descend from it, 3 citing it directly. 1 of the 119 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 deviceK113149 Synthes Uss ConnectorsSynthes Spine · 2012
- Descendant · cites it directly · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 3 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · 4 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- Descendant · 5 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
Showing 5 of 93 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 93 · See all- K120571Synthes Uss ConnectorSynthes Spine · 2012 · cites it directly74descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 3 generations on30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 4 generations on26descendants
- K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 5 generations on21descendants
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) | K113149 | Synthes Uss Connectors | Synthes Spine | 2012 | — |
| +1 | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +3 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +4 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| +5 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 12 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K962608 | Synthes (U.S.a.) Universal Spinal Parallel ConnectorSummary page 1…ss Ill Orthopaedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K962608 Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X,… | 1996 |
| * | K963045 | Synthes (U.S.a.) Universal Sacral SystemSummary page 1…Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K962608 Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031 175 Synthes UISS… | 1997 |
| * | K992739 | Click'xSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K962608 Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031 175 Synthes UISS Illiosacral and Polyaxial, K(082572… | 2000 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…dicates: Synthes UISS, K962608 Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031 175 Synthes UISS Illiosacral and Polyaxial, K(082572 Synthes Matrix System, K092929… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…S, K963045 Synthes Click'X, K992739 Synthes Click'X, K031 175 Synthes UISS Illiosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K1 00634 Syn… | 2008 |
| * | K092929 | Synthes Matrix SystemSummary page 1…992739 Synthes Click'X, K031 175 Synthes UISS Illiosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K1 00634 Synthes Matrix System, 100952 Synt… | 2009 |
| * | K100634 | Synthes Matrix SystemSummary page 1…75 Synthes UISS Illiosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K1 00634 Synthes Matrix System, 100952 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 Device… | 2010 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 1…Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K1 00634 Synthes Matrix System, 100952 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 Device The Synthes UISS Line Extension is an additi… | 2010 |
| * | K103287 | Synthes 6.0 Cocr and CPT TI-3 RodsSummary page 1…, K092929 Synthes Matrix System, K1 00634 Synthes Matrix System, 100952 Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 Device The Synthes UISS Line Extension is an addition to Synthes' existing non- Description: cervical spina… | 2011 |
What descends from it? (93)
See all 933 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 13 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120571 (Synthes Spine, 2012) has gone furthest, with 74 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedlicle screw fixation (Ti -S2/ilium), posterior hock fixation (TI 1-5), 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 (383 words)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedlicle screw fixation (Ti -S2/ilium), posterior hock fixation (TI 1-5), 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 lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DOD), 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 6.0mmn rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mmn parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mmn parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mmn rod systems. Whien used with the 5.5/6.0mmn extension connectors, Matrix can be linked to the Synthes USS 6.0mmn rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mmn rod systems to one another.
When used with the 3.5/6.0mmn and 4.0/6.0mmn tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mmn 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 4.0mmn 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 6.0mmn cobalt-chromium-molybdenumn alloy and titanium grade 3 rods, which can only be used with Pangea.
SvnthesUSS
* 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
CetviFIx
* 3.5mm Rod Systems: GerviFix, Axon, Synapse/c
* 4.0mm Rod System: Synapse
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113149: Synthes Uss Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113149
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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