# K201315: PERFORM Humeral System – Stem

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Sep 11, 2020 after 116 days
- Product code: PAO (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K911686 (1991). 139 ancestors in all.
11 later devices descend from it; 6 cite it directly.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190521: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2019) Summary page 5.

## Most influential descendants
- K212800: PRIMA Humeral System and SMR Glenosphere Ø42 (2022), 2 descendants of its own
- K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (2024), 1 descendant of its own
- K240876: Identity Shoulder System (2024), 1 descendant of its own
- K233712: PRIMA Humeral System; PRIMA TT Glenoid (2024), 1 descendant of its own
- K230572: AETOS Shoulder System (2023), 1 descendant of its own

## Recalls of this device
- Aug 29, 2024 · Class II · Z-3309-2024: Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

## Indications for use
In Anatomic: The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by: • Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis • Correction of functional deformity • Post-traumatic arthritis • Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: • Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis • Pseudoparalysis or anterior superior escape • Rotator cuff tear arthropathy • Correction of functional deformity • Post-traumatic arthritis • Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Source page: https://510kreport.com/device/K201315
Methodology: https://510kreport.com/methodology