ARROW Reverse Shoulder long keel and short keel glenoid base
FDA 510(k) K142778 · Fournitures Hospitalieres Industrie
510(k) numberK142778
Submission
- Device name
- ARROW Reverse Shoulder long keel and short keel glenoid base
- Applicant
- Fournitures Hospitalieres Industrie
Quimper, FR - Received
- September 26, 2014
- Decision date
- March 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K171789 | ARROW Reverse Porous GlenoidPHX · Traditional | 01/23/2018SE |
| K163148 | BePOD® Foot ScrewsHWC · Traditional | 09/14/2017SE |
| K163710 | BePOD® EZ Weil ScrewsHWC · Traditional | 09/08/2017SE |
| K162068 | ARROW Anatomical Porous glenoidMBF · Traditional | 04/10/2017SE |
| K170040 | BePOD Cannulated Arthrodesis ScrewsHWC · Traditional | 04/04/2017SE |
| K150568 | ARROW Humeral stems size 6 and 16PHX · Traditional | 10/29/2015SE |
| K150471 | CalcaNail Orthopedic Arthrodesis NailHSB · Traditional | 05/22/2015SE |
| K150463 | CalcaNail Orthopedic NailHSB · Traditional | 05/22/2015SE |
| K120740 | Cols® Fixation SystemMBI · Special | 03/05/2013SE |
| K112193 | Arrow Reverse Shoulder SystemPHX · Traditional | 07/12/2012SE |
Questions and answers
When was ARROW Reverse Shoulder long keel and short keel glenoid base cleared by the FDA?
ARROW Reverse Shoulder long keel and short keel glenoid base (K142778) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 175 days after the submission was received.
What is the product code of K142778?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.