510(k) · Cleared
ClearedSynthes Uss Connector
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 14, 2012 as substantially equivalent to K963045 (Synthes (Usa), 1997) and 9 other predicates after a 77-day review. Its family tree reaches back 8 generations to 1995. 1 of the 154 devices in its family, counting itself, has a Class I recall. 74 later devices descend from it.
- Decided
- May 14, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K950697 (1995). 79 ancestors in all, the oldest K781443 (1978). 74 later devices descend from it, 2 citing it directly. 1 of the 154 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 1 generation backK113044 Synthes MirsSynthes Spine · 2011 · Recalled
- This deviceK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · cites it directly · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 2 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · 3 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- Descendant · 4 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- Descendant · 2 generations on · 19 of its ownK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
Showing 5 of 74 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 74 · See all- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 2 generations on30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 3 generations on26descendants
- K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 4 generations on21descendants
- K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −1 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
| 0 (this device) | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +1 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +2 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| +4 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| +2 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 1 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 8 | 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.
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? (10)
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…ss Ill Orthopaedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031175 Synthes UISS… | 1997 |
| * | K992739 | Click'xSummary page 1…habilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031175 Synthes UISS Iliosacral and Polyaxial, K(082572… | 2000 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031175 Synthes UISS Iliosacral and Polyaxial, K(082572 Synthes Matrix System, K092929… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…ISS, K963045 Synthes Click'X, K992739 Synthes Click'X, K031175 Synthes UISS Iliosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 S… | 2008 |
| * | K092929 | Synthes Matrix SystemSummary page 1…K992739 Synthes Click'X, K031175 Synthes UISS Iliosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100952 S… | 2009 |
| * | K100634 | Synthes Matrix SystemSummary page 1…5 Synthes UISS Iliosacral and Polyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100952 Synthes USS Connectors, K1 11358… | 2010 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 1…olyaxial, K(082572 Synthes Matrix System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100952 Synthes USS Connectors, K1 11358 Synthes MIRS, K1I13044 Synthes… | 2010 |
| * | K111358 | Synthes UssSummary page 1…x System, K092929 Synthes Matrix System, K100634 Synthes Matrix System, K100952 Synthes USS Connectors, K1 11358 Synthes MIRS, K1I13044 Synthes USS Connectors, K1 13149 Device The Syn… | 2011 |
| * | K113044 | Synthes Mirs | 2011 |
| * | K113149 | Synthes Uss ConnectorsSummary page 1…Matrix System, K100952 Synthes USS Connectors, K1 11358 Synthes MIRS, K1I13044 Synthes USS Connectors, K1 13149 Device The Synthes UISS Connector is an addition to Synthes' existing Description: non-cervical spinal fi… | 2012 |
What descends from it? (74)
See all 742 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 · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 11 of the 79 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133746 (Biomet Spine (Aka Ebi, LLC), 2014) has gone furthest, with 67 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 UISS 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 UISS, 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 (483 words)
The Synthes UISS 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 UISS, 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 pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes UISS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature UISS can be linked to the Synthes UISS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes UISS 5.5 mm rod systems can be linked to the Synthes UISS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes UISS 5.5 mm rod systems to one another. 6.0 mm/6.0mm 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/6.0mm and 4.0 mm/6.0mm 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/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes UISS 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/6.0mm tapered rods, the Synthes UISS 6.0 mm rod systems can be linked to the Synthes UISS 5.5 mm rod systems.
In addition, Synthes UISS 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 UISS 5.5 mm rod systems can be interchanged with all UISS 5.5 mm rods and transconnectors.
Synthes USS
* 6.0 mm Rod Systems: UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Panges, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, ClampFix
* 5.5 mm Rod Systems: Matrix, MIRS
* 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/K120571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120571: Synthes Uss Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120571
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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