510(k) Report

FDA applicant

Influence, Inc.

Washington, DC16 decisions1996–19993 recalls

FDA records 16 decisions for Influence, Inc. (Washington, DC) from 1996 to 1999: 16 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HXJ (Staple Driver). Its devices cite 30 predicates, 11 of them its own earlier devices. 3 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 Influence, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Influence, Inc. since 2007.

Recalls per year

2in 2009

2008: 12009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Influence, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue5decisions
  • HXJStaple Driver2decisions
  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…2decisions
  • GEHUnit, Cryosurgical, Accessories2decisions
  • LRKDevice, Anti-Snoring2decisions
  • FENDevice, Cystometric, Hydraulic1decision

Also: HWC (1), FZP (1).

Whose devices does it build on?

Its devices cite 30 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 11 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.

  • K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc. · 19974cite it
  • K981677Repose Bone Screw SystemInfluence, Inc. · 19993cite it
  • K972023Sleep-in Bone Screw SystemInfluence, Inc. · 19973cite it
  • K962372Urotac Bone Anchor InserterInfluence, Inc. · 19962cite it
  • K972622Straight-in Bone Screw Fixation SystemInfluence, Inc. · 19972cite it
  • K982155Short Straight-in Bone Screw Fixation SystemInfluence, Inc. · 19982cite it

What has FDA decided for it lately?

  • K981677Repose Bone Screw SystemInfluence, Inc. · 19992 recalls
  • K991792Cryo-Mono Cryogenic System, Model Cryo-Mono with Tuf ProbeInfluence, Inc. · 1999
  • K992277Stapletac Bone Anchor SystemInfluence, Inc. · 1999
  • K991122Cryo-Mono Cryogrnic SystemInfluence, Inc. · 1999
  • K990160Microtac-Bone Anchor SystemInfluence, Inc. · 1999
  • K990095Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc. · 1999
  • K983325IN-Probe II Urodynamic SystemInfluence, Inc. · 1998
  • K982155Short Straight-in Bone Screw Fixation SystemInfluence, Inc. · 1998

All 16 as Influence, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K981677Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by…Jul 27, 2009
  • K981677Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic…Jul 27, 2009
  • K970292AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal…Jan 28, 2008