KWRClass III

Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

21 CFR 888.3640 / Orthopedic

KWR is the FDA product code for Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented, a class III device type, regulated under 21 CFR 888.3640. FDA's definition for this code reads: "Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: KWR
Device name: Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
FDA definition: Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Regulation: 21 CFR 888.3640
Device class: Class III
Review panel: Orthopedic
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code KWR

FDA records hold no clearances under product code KWR.

Recent recalls

Product code KWR

Z-1918-2014Class IIThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured...The Anspach Effort, Inc. / initiated 2012-11-28 / 1

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)