Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012
FDA 510(k) K100741 · Encore Medical L.P.
510(k) numberK100741
Submission
- Device name
- Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- March 16, 2010
- Decision date
- August 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Other 510(k)s with product code PHX
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|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
More from Depuy Ireland UC
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|---|---|---|
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | 01/15/2026SE |
| K252974 | EMPOWR KneeJWH · Traditional | 12/19/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | 11/12/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | 08/05/2025SE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)JWH · Special | 07/08/2025SE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)JWH · Traditional | 07/02/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | 05/16/2025SE |
| K241483 | ceramys femoral head systemLZO · Traditional | 02/07/2025SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | 05/29/2024SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | 06/23/2023SE |
Questions and answers
When was Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012 cleared by the FDA?
Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012 (K100741) received a 510(k) decision of Substantially Equivalent on August 2, 2010, 139 days after the submission was received.
What is the product code of K100741?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.