510(k) Report

FDA applicant

New Deal, S.A.

Potomac, MD28 decisions1999–200712 recalls

FDA records 28 decisions for New Deal, S.A. (Potomac, MD) from 1999 to 2007: 28 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 62 predicates, 12 of them its own earlier devices. 12 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 New Deal, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2017

2008: 32010: 32011: 12012: 12013: 12017: 2
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — New Deal, S.A. 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?

  • HWCScrew, Fixation, Bone10decisions
  • HRSPlate, Fixation, Bone9decisions
  • JDRStaple, Fixation, Bone4decisions
  • HTYPin, Fixation, Smooth2decisions
  • JDWPin, Fixation, Threaded2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 62 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 85 times; 12 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.

  • K022599Newdeal K WireNew Deal, S.A. · 200223cite it
  • K060473TTC PlateNew Deal, S.A. · 20066cite it
  • K011716The Uni-Clip StapleNew Deal, S.A. · 20016cite it
  • K001231The Kalix ImplantNew Deal, S.A. · 20005cite it
  • K050346Stabilization ScrewNew Deal, S.A. · 20055cite it
  • K021626Hallu PlatesNew Deal, S.A. · 20025cite it

What has FDA decided for it lately?

  • K063820Lisfranc PlateNew Deal, S.A. · 2007
  • K070160Modification to TTC PlatesNew Deal, S.A. · 2007
  • K070241Modification to Lapidus PlateNew Deal, S.A. · 20071 recall
  • K060474Lisfranc PlateNew Deal, S.A. · 2006
  • K061765Kalix II ImplantNew Deal, S.A. · 2006
  • K061594Large Uni-Clip StapleNew Deal, S.A. · 2006
  • K060476Lapidus PlateNew Deal, S.A. · 2006
  • K060473TTC PlateNew Deal, S.A. · 2006

All 28 as New Deal, S.A. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K091788Panta Nail, Rx only, Sterile,Mar 3, 2017Class II
  • K011716The UNI-CP System; Model Number: 330230SND.Jan 25, 2017Class III
  • K050882Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal…May 9, 2013Class II
  • K070241Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive…Feb 9, 2012Class II
  • K050882Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is…May 19, 2011
  • K050882Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package.…Mar 1, 2010