# K082914: Clampfix

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Dec 11, 2008 after 72 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990745 (1999). 9 ancestors in all.
350 later devices descend from it; 1 cites it directly.
1 of 360 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010658: Modified Uss Fracture System, Synthes (Usa) (2001)
- K963045: Synthes (U.S.a.) Universal Sacral System, Synthes (Usa) (1997) Summary page 1.
- K002517: Uss Vas, Synthes (Usa) (2000) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1.
- K010108: Uss-Line Extension, Synthes (2001) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K090605: Clampfix (2009), 349 descendants of its own
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own

## Indications for use
The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: 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 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix). In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix) can be interchanged with all USS 6.0 mm rods and transconnectors.

Source page: https://510kreport.com/device/K082914
Methodology: https://510kreport.com/methodology