# K041066: Encore Reverse Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Mar 24, 2005 after 335 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
303 later devices descend from it; 25 cite it directly.
1 of 304 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023147: Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models Amt-16, Amt-8 & Amt-4, Bortec Biomedical, Ltd. (2002). Our reading of the summary gave K023147, FDA’s number for Analog Multiplexed Cable Telemetry (Amt) Electromyograph… (Bortec Biomedical, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Delta Shoulder”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K051075: Encore Reverse Shoulder Prosthesis (2005), 248 descendants of its own
- K053274: Anatomical Shoulder Inverse/Reverse (2006), 239 descendants of its own
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K052086: Encore Reverse Shoulder Prosthesis Humeral Stem Adapter (2005), 201 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-0098-2024: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
- Aug 8, 2007 · Not classified · Z-0184-2008: Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
- Aug 8, 2007 · Not classified · Z-0185-2008: Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
- Jul 28, 2005 · Not classified · Z-1566-05: Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.

## Indications for use
The Reverse Shoulder is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Source page: https://510kreport.com/device/K041066
Methodology: https://510kreport.com/methodology