510(k) Report

FDA applicant

Ascension Orthopedics, Inc.

Austin, TX29 decisions2002–202419 recalls

FDA records 29 decisions for Ascension Orthopedics, Inc. (Austin, TX) from 2002 to 2024: 29 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KYI (Prosthesis, Wrist, Carpal Trapezium). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 10 of them its own earlier devices. 19 recalls are linked to its devices.

FDA’s records also spell it “Ascension Orthopedics”.

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 Ascension Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12008: 12009: 22010: 62011: 12013: 12014: 12015: 32016: 12017: 12018: 12023: 12024: 1
2007high 6 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

9in 2019

2010: 22013: 12014: 22016: 32017: 12018: 12019: 9
2007high 9 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ascension Orthopedics, 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?

  • HRSPlate, Fixation, Bone4decisions
  • KYIProsthesis, Wrist, Carpal Trapezium3decisions
  • KYJProsthesis, Finger, Constrained, Polymer3decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3decisions
  • HWCScrew, Fixation, Bone3decisions
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2decisions

Also: HSN (2), KWD (2), LZJ (1), KXE (1), KWI (1), KWN (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 150 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 135 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 59 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 10 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.

  • K151459Integra Total Ankle Replacement SystemAscension Orthopedics · 20154cite it
  • K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 20064cite it
  • K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc. · 20043cite it
  • K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 20043cite it
  • K032686Ascension Modular Radial HeadAscension Orthopedics, Inc. · 20033cite it
  • K022892Ascension Sillicone MCPAscension Orthopedics, Inc. · 20023cite it

What has FDA decided for it lately?

  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  • K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
  • K182878Integra Salto Total Ankle SystemAscension Orthopedics · 20188 recalls
  • K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics · 2017
  • K160830Integra External Fixation SystemAscension Orthopedics · 20162 recalls
  • K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics · 2015
  • K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics · 2015
  • K151459Integra Total Ankle Replacement SystemAscension Orthopedics · 20152 recalls

All 22 as Ascension Orthopedics, Inc. →All 7 as Ascension Orthopedics →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K082231Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The…Nov 4, 2019Class II
  • K153452Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190TMar 8, 2019Class II
  • K153452Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192TMar 8, 2019Class II
  • K153452Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193TMar 8, 2019Class II
  • K153452Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191TMar 8, 2019Class II
  • K153452Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182TMar 8, 2019Class II

Other applicant names beginning “Ascension”

FDA records each applicant name separately; these may or may not be the same firm.

Ascension Orthopedic 7