510(k) Report

FDA applicant

Orthopaedic Implant Company

Reno, NV15 decisions2012–20240 recalls

FDA records 15 decisions for Orthopaedic Implant Company (Reno, NV) from 2012 to 2024: 15 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “The Orthopaedic Implant Company”.

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 Orthopaedic Implant Company’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2012: 12014: 12015: 12016: 12017: 12018: 22019: 12021: 22022: 12023: 22024: 2
2012high 2 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Orthopaedic Implant Company by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone5decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component4decisions
  • HSBRod, Fixation, Intramedullary And Accessories2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • HTNWasher, Bolt Nut1decision
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

Also: HWC (1).

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 7 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 49 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 8 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.

  • K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 20212cite it
  • K211112OIC External Fixation SystemOrthopaedic Implant Company · 20211cites it
  • K113123Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) SystemThe Orthopaedic Implant Company · 20121cites it
  • K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 20231cites it
  • K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 20141cites it
  • K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company · 20151cites it

What has FDA decided for it lately?

  • K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company · 2024
  • K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024
  • K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
  • K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2023
  • K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022
  • K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021
  • K211112OIC External Fixation SystemOrthopaedic Implant Company · 2021
  • K183682OIC External Fixation SystemOrthopaedic Implant Company · 2019

All 10 as Orthopaedic Implant Company →All 5 as The Orthopaedic Implant Company →