# K123380: Stride Unicondylar Knee

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: May 31, 2013 after 211 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971938 (1997). 18 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 1.
- K082081: Mako Surgical Corporation Unicondylar Knee Implant System Iii, Mako Surgical Corp. (2008) Summary page 1.

## Most influential descendants
- K163700: Bodycad Unicompartmental Knee System (2017), 8 descendants of its own
- K181302: Bodycad Unicompartmental Knee System (2019), 7 descendants of its own
- K191150: Bodycad Unicompartmental Knee System (2019), 4 descendants of its own
- K191996: BC Reflex Uni Knee System (2019), 3 descendants of its own
- K203697: BC Reflex Uni Knee System (2021), 2 descendants of its own

## Recalls of this device
- Jun 4, 2014 · Class II · Z-1943-2014: Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-0
- Jun 4, 2014 · Class II · Z-1942-2014: Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-0

## Indications for use
The STRIDE Unicondylar Knee devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only.

Source page: https://510kreport.com/device/K123380
Methodology: https://510kreport.com/methodology