Company · US
Ascension Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2024. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | 5 |
| HRS | Plate, Fixation, Bone | 4 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 |
| HWC | Screw, Fixation, Bone | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 3 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 3 |
| --- | 2 | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 2 |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HXX | Screwdriver | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 |
| KWN | Prosthesis, Wrist, Carpal Lunate | 1 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 2024 | K233674 | Freedom Wrist Arthroplasty System Ascension Orthopedics, Inc. | JWJ |
| Dec 14, 2023 | K233670 | Ascension Silicone MCP; Ascension Silicone PIP Ascension Orthopedics, Inc. | KYJ |
| Dec 18, 2018 | K182878 | Integra Salto Total Ankle System Ascension Orthopedics | HSN |
| Jul 14, 2017 | K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System Ascension Orthopedics | HWC |
| Jul 6, 2016 | K160830 | Integra External Fixation System Ascension Orthopedics | KTT |
| Dec 23, 2015 | K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid Ascension Orthopedics | KWS |
| Oct 29, 2015 | K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System Ascension Orthopedics | HWC |
| Aug 31, 2015 | K151459 | Integra Total Ankle Replacement System Ascension Orthopedics | HSN |
| Nov 14, 2014 | K142413 | TITAN Modular Total Shoulder System Ascension Orthopedics | KWS |
| Feb 13, 2013 | K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM Ascension Orthopedics, Inc. | HRS |
| Dec 6, 2011 | K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM Ascension Orthopedics, Inc. | HRS |
| Dec 21, 2010 | K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY Ascension Orthopedics, Inc. | LZJ |
| Aug 30, 2010 | K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM Ascension Orthopedics, Inc. | KWS |
| Aug 2, 2010 | K100502 | ASCENSION TOTAL PLATE SYSTEM Ascension Orthopedics, Inc. | HRS |
| Jul 12, 2010 | K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM Ascension Orthopedics, Inc. | HSB |
| Jun 16, 2010 | K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM Ascension Orthopedics, Inc. | HRS |
| Jan 14, 2010 | K092047 | ASCENSION METAL GREAT TOE SYSTEM Ascension Orthopedics, Inc. | KWD |
| Nov 5, 2009 | K092440 | ASCENSION CANNULATED SCREW SYSTEM Ascension Orthopedics, Inc. | HWC |
| Jan 12, 2009 | K082231 | ASCENSION SILICONE PIP Ascension Orthopedics, Inc. | KYJ |
| Jun 17, 2008 | K080997 | ASCENSION PYROCARBON LUNATE Ascension Orthopedics, Inc. | KWN |
| Jun 22, 2007 | K071064 | ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA Ascension Orthopedics, Inc. | HSD |
| Oct 31, 2006 | K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM Ascension Orthopedics, Inc. | HSD |
| Aug 11, 2006 | K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 Ascension Orthopedics, Inc. | KYI |
| May 5, 2006 | K060560 | ASCENSION PYROSPHERE CMC/TMT Ascension Orthopedics, Inc. | KWD |
| Nov 3, 2005 | K052137 | ASCENSION MUH Ascension Orthopedics, Inc. | KXE |
| Nov 13, 2004 | K042690 | ASCENSION PYROSPHERE (PCS) Ascension Orthopedics, Inc. | KYI |
| Aug 25, 2004 | K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 Ascension Orthopedics, Inc. | KYI |
| Oct 22, 2003 | K032686 | ASCENSION MODULAR RADIAL HEAD Ascension Orthopedics, Inc. | KWI |
| Nov 25, 2002 | K022892 | ASCENSION SILLICONE MCP Ascension Orthopedics, Inc. | KYJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2018 | Ascension Orthopedics, Inc Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW Terminated |
HSD | K062861 |
| Feb 17, 2012 | Ascension Orthopedics, Inc 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 Terminated |
KXE | None listed |
| Nov 22, 2010 | Ascension Orthopedics, Inc 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 Terminated |
KYI | K041451 |
| Nov 22, 2010 | Ascension Orthopedics, Inc 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 Terminated |
KYI | K041451 |
| May 4, 2010 | Ascension Orthopedics, Inc 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 a Terminated |
NEG | None listed |
| Jun 26, 2009 | Ascension Orthopedics, Inc 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 screwdriv Terminated |
HXX | K022324 K022325 |
| Jul 20, 2004 | Ascension Orthopedics, Inc Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas Terminated |
NEG | None listed |
| Feb 8, 2003 | Ascension Orthopedics, Inc Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal Terminated |
--- | None listed |
| Feb 8, 2003 | Ascension Orthopedics, Inc 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 Terminated |
--- | None listed |