(228 days)
Not Found
No
The document describes a mechanical prosthetic device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a shoulder prosthesis indicated for the relief of pain and restoration of function in various degenerative joint diseases and fractures, which are therapeutic goals.
No
This device is a shoulder prosthesis, indicated for the treatment of pain and restoration of function in various shoulder conditions. It is an implant designed for replacement, not for diagnosing conditions.
No
The device description clearly states it is a modular total shoulder replacement comprised of physical components (humeral stem, modular head, and glenoid) made from materials like cobalt-chrome alloy and UHMWPE. This indicates it is a physical medical device, not software-only.
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.
- Device Description: The Oxford Modular Shoulder Prosthesis is a surgical implant designed to replace a damaged shoulder joint. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use is to relieve pain and restore function in the shoulder joint due to various conditions. This is achieved through the physical presence and function of the implant, not through testing bodily samples.
The provided information clearly describes a medical device used in vivo (within the body) for surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:
- osteoarthritis .
- rheumatoid arthritis .
- revision cases where other devices or treatments have failed .
- correction of functional deformity .
- treatment of acute fracture of the humeral head unmanageable using other treatment . methods
- cuff tear arthroplasty t
Hemi-resurfacing is also indicated for:
- humeral head fractures ●
- avascular necrosis of the femoral head .
Product codes (comma separated list FDA assigned to the subject device)
KWS; HSD
Device Description
The Oxford Modular Shoulder is a modular total shoulder replacement comprised of 3 components: humeral stem, modular head and glenoid.
The humeral stem and head are made from cobalt-chrome alloy; the glenoid component is made from ultra high molecular weight polyethylene (UHMWPE). The humeral stem has a proximal one-third plasma sprayed coating to provide fixation and a proximal fin with holes to allow for reconstruction of fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder 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)
Testing that has been performed accordingly includes:
- . static shear testing of the plasma sprayed surface coating
- static tensile testing of the plasma sprayed surface coating ●
- microstructure and metallurgy analysis of surface coating ●
On the basis of the above SE table and the test results provided, this device is substantially equivalent to the predicate device.
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
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
KO12377 p/3
MAR 11 2002
510(k) SUMMARY
Device: Oxford Modular Shoulder Prosthesis
Date: 07/17/01
Corin USA Applicant's name: 10500 University Center Drive, Suite 190 Tampa, FL 33612
Phone: (813) 977-4469 (813) 979-0042 Fax:
- Contact person: Joel Batts, Regulatory Affairs Manager
Shoulder joint humeral (hemi-shoulder) metallic Classification name: uncemented prosthesis (87HSD)
Shoulder joint metal/polymer semi-constrained cemented prosthesis (87KWS)
C.F.R. section: 21.888.3660, 21.888.3690
Device class: II
Classification panel: Orthopedic
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Indications for use
The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:
- osteoarthritis
- rheumatoid arthritis .
- . revision cases where other devices or treatments have failed
- correction of functional deformity ●
Section 2 Page 1 of 3
1
-
cuff tear arthroplasty .
Hemi-resurfacing is also indicated for: -
. humeral head fractures
-
avascular necrosis of the femoral head ●
Device description
The Oxford Modular Shoulder is a modular total shoulder replacement comprised of 3 components: humeral stem, modular head and glenoid.
The humeral stem and head are made from cobalt-chrome alloy; the glenoid component is made from ultra high molecular weight polyethylene (UHMWPE). The humeral stem has a proximal one-third plasma sprayed coating to provide fixation and a proximal fin with holes to allow for reconstruction of fractures.
Substantial equivalence basis
Based on the following SE table, which compares the Oxford Modular Shoulder to the Biomet Bio-Modular Shoulder (K992119), and the risk analysis, the former is believed to be substantially equivalent.
| Features | Oxford
Modular
Shoulder | Biomet Bio-
Modular Shoulder
System (K992119) |
|----------------------------------------------------------------|-------------------------------|-----------------------------------------------------|
| Humeral stem substrate | CoCr | Ti6Al4V |
| Indications for use, in
the submission, apply | Yes | Yes |
| Proximal plasma
sprayed titanium coating
on humeral stem | Yes | Yes |
| Lateral fin and finholes
on humeral stem | Yes | Yes |
| Collar on humeral stem | No | Yes |
| Humeral stem lengths | 120mm and
200mm | 115mm and 190mm |
| CoCr modular heads | Yes | Yes |
| Keeled all-UHMWPE
glenoid component | Yes | Yes |
| Glenoid component | 2 sizes, 1 | 3 sizes, 2 |
| sizes | thickness | thicknesses |
2
The guidance document entitled, "Guidance Document For Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Cement" was consulted during the compilation of this submission. Testing that has been performed accordingly includes:
- . static shear testing of the plasma sprayed surface coating
- static tensile testing of the plasma sprayed surface coating ●
- microstructure and metallurgy analysis of surface coating ●
On the basis of the above SE table and the test results provided, this device is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 11 2002
Mr. Joel Batts Regulatory Affairs Manager Corin USA 10500 University Center Drive, Suite 190 Tampa, Florida 33612
Re: K012377
Trade/Device Name: Oxford Modular Shoulder Prosthesis Regulation Number: 21 CFR §888.3660; §888.3690 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic cemented or uncemented prosthesis Regulatory Class: Class II
Product Code: KWS; HSD Dated: December 7, 2001 Received: December 11, 2001
Dear Mr. Batts:
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 vour 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.
4
Page 2 - Mr. Joel Batts
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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,
Sincerely yours,
Mark M. Milliken
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
5
K012377
page 1 of 1
INDICATIONS FOR USE
The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:
- osteoarthritis .
- rheumatoid arthritis .
- revision cases where other devices or treatments have failed .
- correction of functional deformity .
- treatment of acute fracture of the humeral head unmanageable using other treatment . methods
- cuff tear arthroplasty t
Hemi-resurfacing is also indicated for:
- humeral head fractures ●
- avascular necrosis of the femoral head .
Mark A. Milliken
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012377
Section 6 Page 1 of 1