Ascension Orthopedics, Inc.
Austin, TX, US
Ascension Orthopedics, Inc. appears in FDA device records in Austin, TX. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for Ascension Orthopedics, Inc. between 2002 and 2024. The busiest year on record is 2010, with 6. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 6 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233674 | Freedom Wrist Arthroplasty System | JWJ | Substantially Equivalent | |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | KYJ | Substantially Equivalent | |
| K182878 | Integra Salto Total Ankle System | HSN | Substantially Equivalent | |
| K162153 | Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System | HWC | Substantially Equivalent | |
| K160830 | Integra External Fixation System | KTT | Substantially Equivalent | |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | KWS | Substantially Equivalent | |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System | HWC | Substantially Equivalent | |
| K151459 | Integra Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K142413 | TITAN Modular Total Shoulder System | KWS | Substantially Equivalent | |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | HRS | Substantially Equivalent | |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | HRS | Substantially Equivalent | |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | LZJ | Substantially Equivalent | |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | HRS | Substantially Equivalent | |
| K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM | HSB | Substantially Equivalent | |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | HRS | Substantially Equivalent | |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | KWD | Substantially Equivalent | |
| K092440 | ASCENSION CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K082231 | ASCENSION SILICONE PIP | KYJ | Substantially Equivalent | |
| K080997 | ASCENSION PYROCARBON LUNATE | KWN | Substantially Equivalent | |
| K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA | HSD | Substantially Equivalent | |
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM | HSD | Substantially Equivalent | |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | KYI | Substantially Equivalent | |
| K060560 | ASCENSION PYROSPHERE CMC/TMT | KWD | Substantially Equivalent | |
| K052137 | ASCENSION MUH | KXE | Substantially Equivalent | |
| K042690 | ASCENSION PYROSPHERE (PCS) | KYI | Substantially Equivalent | |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 | KYI | Substantially Equivalent | |
| K032686 | ASCENSION MODULAR RADIAL HEAD | KWI | Substantially Equivalent | |
| K022892 | ASCENSION SILLICONE MCP | KYJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014207283 | 3002788818 | Ascension Orthopedics, Inc. | 11101 Metric Blvd, Austin, TX 78758 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
- HRSPlate, Fixation, Bone
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- KYJProsthesis, Finger, Constrained, Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- KWDProsthesis, Toe, Hemi-, Phalangeal
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- KWNProsthesis, Wrist, Carpal Lunate
- KYIProsthesis, Wrist, Carpal Trapezium
- KXEProsthesis, Wrist, Hemi-, Ulnar
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0794-2019 | Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW | The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). | Class III | Terminated | |
| Z-1060-2012 | Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis | A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA. | Terminated | ||
| Z-0438-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal. | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. | Terminated | ||
| Z-0437-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal. | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. | Terminated | ||
| Z-1524-2010 | Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis. | Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant. | Terminated | ||
| Z-1524-2009 | Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver. | Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery. | Terminated | ||
| Z-1025-04 | Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas | Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility. | Terminated | ||
| Z-0550-03 | Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal | Literature approved for international distribution only was distributed domestically. | Terminated | ||
| Z-0549-03 | Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005 | Brochures approved for international distribution only were distributed domestically. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain