Acumed Modular Shoulder System
FDA 510(k) K992525 · Acu Med, Inc.
510(k) numberK992525
Submission
- Device name
- Acumed Modular Shoulder System
- Applicant
- Acu Med, Inc.
Beaverton, OR, US - Received
- July 28, 1999
- Decision date
- February 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3690
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233260 | Univers Revers CA Head and AdapterHSD · Traditional | Arthrex, Inc. | 02/12/2024SE |
| K221232 | Univers Revers Humeral Cup ImplantHSD · Special | Arthrex, Inc. | 05/19/2022SE |
| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | Implantcast GmbH | 11/12/2020SE |
| K193122 | Biocore9 Humeral Resurfacing SystemHSD · Traditional | Biocore9, LLC | 05/15/2020SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | Arthrosurface, Inc. | 04/18/2018SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | Arthrex, Inc. | 11/21/2016SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | Zimmer GmbH | 11/01/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | Arthrex, Inc. | 04/19/2016SE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special | Arthrosurface, Inc. | 12/19/2014SE |
| K131298 | Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional | Exactech, Inc. | 11/26/2013SE |
More from Exactech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021321 | Wrist Fusion PlateHRS · Traditional | 07/17/2002SE |
| K013616 | Polarus Cap ScrewHSB · Traditional | 12/19/2001SE |
| K012655 | Congruent Bone Plate SystemHRS · Traditional | 11/07/2001SE |
| K993657 | Acumed Suture AnchorMBI · Traditional | 01/13/2000SE |
| K980103 | Acumed Suture AnchorMBI · Traditional | 03/16/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | 03/17/1997SE |
| K965029 | Stableloc II External FixatorJEC · Traditional | 02/19/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
| K963026 | TBDHSB · Traditional | 10/28/1996SE |
| K963118 | Extremity Bone ScrewHWC · Traditional | 10/10/1996SN |
Questions and answers
When was Acumed Modular Shoulder System cleared by the FDA?
Acumed Modular Shoulder System (K992525) received a 510(k) decision of Substantially Equivalent on February 4, 2000, 191 days after the submission was received.
What is the product code of K992525?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.