← Product Code [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD) · K031971 # GLOBAL CAP RESURFACING REPLACEMENT SHOULDER (K031971) _DePuy Orthopaedics, Inc. · HSD · Sep 24, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K031971 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD.md) - **Decision Date:** Sep 24, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3690 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only. ## Device Story Global CAP Resurfacing Replacement Shoulder is a cementless humeral head prosthesis; used for hemi or total shoulder replacement. Device restores shoulder alignment, flexion, and extension; reduces pain; resists dislocation. Intended for patients with sufficient bone stock and functional rotator cuff. Implanted by orthopedic surgeons in clinical settings. Device features Cobalt Chrome Molybdenum alloy construction with porocoat application on non-articulating surfaces and proximal stem. Available in 40mm to 56mm curvature sizes and 15mm to 18mm head sizes. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Humeral head prosthesis; material: ASTM F-75 Cobalt Chrome Molybdenum alloy; surface treatment: porocoat on non-articulating surfaces and proximal stem; cementless fixation; curvature sizes 40-56mm; head sizes 15-18mm. ## Regulatory 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. ## Predicate Devices - Copeland Shoulder MB/HA Resurfacing Head ([K010827](/device/K010827.md)) - DePuy Global Advantage Shoulder ([K911686](/device/K911686.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K031971 SEP 2 4 2003 ## 510(k) Summary 2 P. I | Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact Person: | Tiffani Rogers
Clinical Research Specialist, Product Development
Phone: (574) 371-4927
FAX: (574) 371-4987 | | Trade Name: | Global CAP Resurfacing Replacement Shoulder | | Common Name: | Resurfacing shoulder | | Classification: | Class II Device per 21 CFR 888.3690:
Shoulder joint, humeral (hemi-shoulder), metallic
uncemented prosthesis. | | Device Product Code: | HSD | | Panel: | Orthopaedic | | Performance Standards: | No performance standards have been established
under Section 514 of the Federal Food, Drug, and
Cosmetic Act for humeral shoulder prosthesis. | | Substantially Equivalent Devices: | Copeland Shoulder MB/HA Resurfacing Head
K010827
DePuy Global Advantage Shoulder
K911686
(Formerly the Global Total Shoulder) | | Device Description: | The Global CAP Resurfacing Shoulder is a
cementless humeral head to be used for the
treatment of shoulder joints:
• The humeral head is made of ASTM F-75
Cobalt Chrome Molybdenum alloy with a
porocoat application on the non-articulating
surface and the proximal stem. Curvature sizes
are available in 40mm to 56mm (in 4mm
increments) with head sizes of 15mm, 18mm | {1}------------------------------------------------ 031971 p. 2/2 ## 510(k) Summary (continued) The DcPuy Global CAP Resurfacing Shoulder is Indications for use: intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Shoulder is intended for cementless use only. Substantial equivalence: The DePuy Global CAP Resurfacing Shoulder is manufactured from the same material, sterilized and packaged in the same fashion and has the same intended use and design features as the predicate devices and is therefore substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 4 2003 Ms. Tiffani Rogers Clinical Research Specialist, Product Development DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K031971 Trade/Device Name: Global CAP Resurfacing Replacement Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: June 24, 2003 Received: June 26, 2003 Dear Ms. Rogers: 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}------------------------------------------------ Page 2 - Ms. Tiffani Rogers 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) 594-4659. 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/dsma/dsmamain.html Sincerely yours, R. Mark N. Milken 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}------------------------------------------------ K03197 510(k) Number (if known): ## Device Name: Global CAP Resurfacing Replacement Shoulder ## Indications for Use: The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only. Mark N. Milkena (Division Sign-Off) Division of General. Restorative and Neurological Devices K031971 510(k) Number Concurrence of CDRH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K031971](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K031971) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com