Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained (PKC) contract manufacturers
21 US facilities list FDA product code PKC as a contract manufacturer (15) or contract sterilizer (7).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Product code
- PKC (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 888.3660
- Classification panel
- Orthopedic
- FDA flags
- implant
Where they are
Indiana 5 · Ohio 4 · Florida 2 · Illinois 2 · Texas 2 · Massachusetts 1 · Minnesota 1 · Mississippi 1 · New York 1 · Pennsylvania 1 · Utah 1
All 21 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| APS MATERIALS, INC. | 1529009 | Contract manufacturer | Orthopedic; Dental | Dayton, OH | Not verified | Oct 21, 2026 |
| Arthrex, Inc. | 3010331645 | Contract manufacturer and sterilizer | Orthopedic; General and plastic surgery; General hospital +9 more | Ave Maria, FL | Not verified | Oct 21, 2026 |
| INCIPIO DEVICES | 3011015572 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology | Huntington, IN | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Northborough, MA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| MICROPULSE INC | 1834379 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +1 more | Columbia City, IN | Not verified | Oct 21, 2026 |
| Millstone Medical Outsourcing LLC | 3010097171 | Contract manufacturer | Orthopedic; General and plastic surgery; Cardiovascular +10 more | Olive Branch, MS | Not verified | Oct 21, 2026 |
| NORWOOD MEDICAL LLC | 1531174 | Contract manufacturer | Orthopedic; General and plastic surgery; Gastroenterology and urology +1 more | Dayton, OH | Not verified | Oct 21, 2026 |
| PARAGON MEDICAL, INC. | 1834331 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +4 more | Pierceton, IN | Not verified | Oct 21, 2026 |
| PERRYMAN COMPANY | 3009882462 | Contract manufacturer | Orthopedic; Gastroenterology and urology; Neurology +1 more | Houston, PA | Not verified | Oct 21, 2026 |
| Paragon Medical - Dayton | 1000200989 | Contract manufacturer | Orthopedic; General and plastic surgery; Ear, nose and throat +1 more | Dayton, OH | Not verified | Oct 21, 2026 |
| Paragon Medical Inc. | 1000517406 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology | Smithfield, UT | Not verified | Oct 21, 2026 |
| Paragon Medical Inc. | 1835831 | Contract manufacturer | Orthopedic; General and plastic surgery | Castleton, IN | Not verified | Oct 21, 2026 |
| ProMade PoC Center for Complex Orthopedic Solutions at HSS | 3020967480 | Contract manufacturer | Orthopedic | Manhattan, NY | Not verified | Oct 21, 2026 |
| QUALITY TECH SERVICES, LLC | 3003477135 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +11 more | Bloomington, MN | Not verified | Oct 21, 2026 |
| REVELATION MEDICAL DEVICES, LLC | 1836116 | Contract manufacturer | Orthopedic; General and plastic surgery | Auburn, IN | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 1054811 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +13 more | Mulberry, FL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1649518 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +13 more | Fort Worth, TX | Not verified | Oct 21, 2026 |
| Sterigenics US, LLC | 1526534 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Lewis Center, OH | Not verified | Oct 21, 2026 |
| TURNCO TOOL & INSTRUMENT, INC. | 3009241418 | Contract manufacturer | Orthopedic; General and plastic surgery; Dental +1 more | Georgetown, TX | Not verified | Oct 21, 2026 |
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