(90 days)
Not Found
No
The document describes a mechanical implant for joint replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "implant" and a "prosthesis" intended for "replacement of the distal ulnar head" for various arthritic conditions. This directly addresses medical conditions and restores physiological function, which is the definition of a therapeutic device.
No
The device, Ascension® MUH, is an implant designed for replacement of the distal radioulnar joint due to arthritis, not for diagnosing medical conditions.
No
The device description clearly states it is a "single-use, two-component, modular prosthesis" made from metal alloys, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, or to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- This device is an implantable prosthesis. It is surgically placed within the body to replace a damaged joint. Its purpose is to restore function and reduce pain, not to diagnose or analyze biological samples.
The description clearly states it's a "modular prosthesis designed for replacement of the ulnar head," which is a surgical implant.
N/A
Intended Use / Indications for Use
The Ascension® MUH implant is intended for replacement of the distal radioulnar joint:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:
- Pain and weakness of the wrist joint not improved by conservative treatment
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes
- Failed ulnar head resection
Product codes (comma separated list FDA assigned to the subject device)
87 KXE
Device Description
The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radioulnar joint, distal ulnar head, wrist joint, intramedullary canal of the distal end of the ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.
0
K052137 p½
Page 26 of 86
510(k) SUMMARY
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, C-100
Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| 510(k) CONTACT: | Glen Neally
Phone: (512) 836-5001 |
| TRADE NAME: | Ascension® MUH |
| COMMON NAME: | ulnar head prosthesis |
| CLASSIFICATION: | 21 CFR §888.3810 |
| PRODUCT CODE: | 87 KXE |
| PANEL: | Orthopedic |
PREDICATE DEVICE:
Avanta Orthopaedics, Inc., Ulnar Head Implant (K010786)
DEVICE DESCRIPTION:
The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.
INTENDED USE:
The Ascension® MUH implant is intended for replacement of the distal radioulnar joint:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:
- . Pain and weakness of the wrist joint not improved by conservative treatment
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
- Failed ulnar head resection .
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of identical materials and nearly identical design features, demonstrate that the Ascension® MUH is substantially equivalent to the predicate device as indicated in the chart below:
1
| Comparison
| Feature | Ascension Modular Ulnar Head | Avanta Ulnar Head Implant |
|---|---|---|
| Design | Two-piece modular implant | Two-piece modular implant |
| Material (Head) | ASTM F1537 cobalt chromium | ASTM F1537 cobalt chromium |
| Material (Stem) | ASTM F136 Ti6Al4V ELI | CpTi |
| Assembly | Taper connection | Taper connection |
| Fixation | Stem in medullary canal | Stem in medullary canal |
| Articulation | Hemi | Hemi |
| Use | Single use only, surgical implantation longer than 30 days | Single use only, surgical implantation longer than 30 days |
| Sterilization by | ||
| user | Resterilization of device is not recommended. | Resterilization of device is not recommended. |
| Packaging | Double barrier assembly in paperboard box | Double barrier assembly in paperboard box |
| Accessories | Sterilizable instrumentation is available separately (not provided sterile). | Sterilizable instrumentation is available separately (not provided sterile). |
| Stem surface | ||
| finish | Roughened | Roughened |
| Available sizes | Three heads: | |
| (3 diameters) | ||
| Nine stems | Three heads: | |
| (3 diameters) | ||
| Six stems |
Similarities of the Ascension® MUH implant and the Avanta Ulnar Head Implant include: Both devices have the same indications for use; Both devices are made of the same industry standard materials; No new materials are introduced in either product; Both devices are placed into the intramedullary canal of the distal end of the ulna; Both devices are a hemi articulation; Both devices are intended for surgical implantation longer than 30 days: Both devices are intended for single use only.
Summary:
The Ascension® MUH is functionally identical, comparably sized, and has a similar design as compared to the Avanta Ulnar Head Implant. Individual components for the subject and predicate device are provided sterile in individual packages. The Ascension® MUH shares identical indications for use with the predicate device, and is fabricated from the same material as the predicate device. Therefore, the Ascension® MUH is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2005
Glen Neally Director of QA/RA Ascension Orthopedics, Inc. 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832
Re: K052137
Trade/Device Name: Ascension® MUH Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: July 22, 2005 Received: August 5, 2005
Dear Mr. Neally:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(K) Number: K052137
Ascension® MUH Device Name:
Indications for Use:
The Ascension® MUH is intended for replacement of the distal radioulnar joint:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:
- Pain and weakness of the wrist joint not improved by conservative treatment .
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
- Failed ulnar head resection .
Contraindications
- Malunited forearm fractures that preclude stabalization of the ulnar head during . pronation/supination
- . Tendon, ligament, or distal radioulnar joint which cannot provide adequate support or fixation for the prostheses
- Inadequate skin or musculotendinous system .
- Growing patients with open epiphyses .
- Previous open fracture or infection in or around the joint . Known sensitivity to materials used in this device
X Prescription Use (Part 21 CFR 801Subpart B) Over-The-Counter Use (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
(Division Sign-Off) (Division of General, Restorations of CDRH, Office of Device Evaluation (ODE) and Neurological Devices
OR
510(k) Number K052137