(89 days)
Invalid Request: The field Reference Device(s) is "Not Found".
No
The device description focuses on the materials and components of a mechanical wrist implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is intended to reduce pain, restore alignment, and replace flexion and extension movement in the wrist joint for patients with various wrist disabilities, which are therapeutic functions.
No
Explanation: The device, the DePuy Biax A.F. Wrist System, is a wrist implant intended for treatment and revision of wrist joints, not for diagnosing conditions.
No
The device description clearly states it is a "multiple component system" made of materials like Orthochrome, UHWMPe, and Titanium, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- DePuy Biax A.F. Wrist System: This device is a prosthetic implant designed to be surgically implanted inside the human body to replace a damaged wrist joint. It is a physical device that provides mechanical function, not a test performed on a sample.
The description clearly states its purpose is to replace the wrist joint and restore mobility, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing both the flexion and extension movement in the wrist joint. The Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction. The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery. CAUTION: The DePuy Biax A.F. Wrist System is intended for cemented use only.
Product codes
87 JWJ, JWJ
Device Description
The Biax A.F. Wrist System is a cemented, multiple component system to be used for the treatment, and revision, of wrist joints:
• The radial implant stem is made of ASTM F-75 Orthochrome with an articulating surface of UHWMPe. It is available in small, medium and large sizes.
• The 5-piece metacarpal implant is manufactured from F-75 Orthochrome and Titanium (Ti-6Al-4V ELI). It consists of a fixation plate, cemented and held in place with a central stem and two peripheral screws, and attached to an articulating head. All parts are available in a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist joint
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JUL 1 4 2003
KU31203 Page 4
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Dina L. Weissman, J.D.
Legal Consultant, Regulatory Affairs
Phone: (574) 371-4905
FAX: (574) 371-4987 |
| Trade Name: | Biax A.F. Wrist/Biax Advanced Fixation Wrist |
| Common Name: | Wrist prosthesis |
| Classification: | Class II Device per 21 CFR 888.3800:
Wrist, 3-part metal-plastic articulation, semi-
constrained cemented prosthesis |
| Device Product Code: | 87 JWJ |
| Panel: | Orthopaedic |
| Performance Standards: | No performance standards have been established
under Section 514 of the Federal Food, Drug, and
Cosmetic Act for a wrist prosthesis. |
| Substantially Equivalent Devices: | DePuy Biax Wrist K842266
(Formerly called "Beckenbaugh Wrist Prosthesis")
Kinetikos Universal Total Wrist System K020554 |
| Device Description: | The Biax A.F. Wrist System is a cemented, multiple
component system to be used for the treatment, and
revision, of wrist joints:
• The radial implant stem is made of ASTM F-75
Orthochrome with an articulating surface of
UHWMPe. It is available in small, medium and
large sizes.
• The 5-piece metacarpal implant is manufactured
from F-75 Orthochrome and Titanium (Ti-6Al-
4V ELI). It consists of a fixation plate,
cemented and held in place with a central stem
and two peripheral screws, and attached to an
articulating head. All parts are available in a
variety of sizes. |
1
510(k) Summary (continued)
The DePuy Biax A.F. Wrist System is intended to Indications for use: give patients limited wrist mobility by reducing pain, restoring alignment and replacing both the flexion and extension movement in the wrist joint. The Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction. The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery. CAUTION: The DePuy Biax A.F. Wrist System is intended for cemented use only. The Biax A.F. Wrist System has the same intended Substantial equivalence: use, is manufactured from the same material, is sterilized and packaged in the same way, and has the same design features as the predicate devices
and is therefore substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center is a stylized eagle emblem, which is a common symbol used in US government seals. The eagle is depicted with its wings spread, and its body is formed by three curved lines.
Public Health Service
JUL 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K031203
Trade/Device Name: Biax A.F. Wrist System Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWJ Dated: April 14, 2003 Received: April 16, 2003
Dear Ms. Weissman:
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
3
Page 2 - Ms. Dina L. Weissman, J.D.
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. 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 (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
"Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ Ko 31> 03
Biax A.F. Wrist Device Name:
Indications for Use:
The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the wrist joint.
The DePuy Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction
The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery.
CAUTION: The DePuy Biax A.F. Wrist System is for cemented use only.
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K031203
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR/801.109)
OR
Over-The-Counter Use