510(k) Report

FDA applicant

Spine Smith Partners L.P.

Austin, TX9 decisions2008–20122 recalls

FDA records 9 decisions for Spine Smith Partners L.P. (Austin, TX) from 2008 to 2012: 9 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 15 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Spine Smith Partners L.P.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2008: 42009: 12010: 22012: 2
2008high 4 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2013

2012: 12013: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Spine Smith Partners L.P. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spine Smith Partners L.P.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions
  • MQPSpinal Vertebral Body Replacement Device1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

Whose devices does it build on?

Its devices cite 15 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 20125cite it
  • K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P. · 20105cite it
  • K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 20093cite it
  • K073320Cimplicity Spinal SystemSpine Smith Partners L.P. · 20082cite it
  • K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P. · 20081cites it
  • K122168Visualif Challenging Access PlateSpine Smith Partners L.P. · 20121cites it

What has FDA decided for it lately?

  • K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
  • K122168Visualif Challenging Access PlateSpine Smith Partners L.P. · 2012
  • K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P. · 20101 recall
  • K101085Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 20101 recall
  • K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 2009
  • K082821Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemSpine Smith Partners L.P. · 2008
  • K081132Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemSpine Smith Partners L.P. · 2008
  • K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008

All 9 as Spine Smith Partners L.P. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K102090VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations…Jul 31, 2013Class II
  • K101085Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use…Aug 24, 2012Class II