# K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Nov 15, 2016 after 144 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911686 (1991). 27 ancestors in all.
53 later devices descend from it; 21 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081059: Aequalis Reversed Shoulder Prosthesis, Tornier (2008) Summary page 4.

## Most influential descendants
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own
- K200171: SMR TT Augmented Glenoid System (2020), 11 descendants of its own
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (2021), 8 descendants of its own
- K210717: Bone Screws dia. 5,0 mm (2021), 8 descendants of its own
- K220792: SMR Reverse Liner (2022), 7 descendants of its own

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1237-2026: A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surger
- Sep 15, 2023 · Class II · Z-0113-2024: One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able
- May 3, 2022 · Class II · Z-1216-2022: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

## Indications for use
The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: • Rheumatoid arthritis • Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) • Correction of functional deformity • Fractures of the humeral head • Traumatic arthritis • Revision of the devices if sufficient bone stock remains. Notes: • All components are single use. • The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

Source page: https://510kreport.com/device/K161742
Methodology: https://510kreport.com/methodology