# K223069: Modular Rotating Hinge Knee Systems and Compatible Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Apr 21, 2023 after 203 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811630 (1981). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994207: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 9.

## Most influential descendants
- K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (2023), 3 descendants of its own
- K251665: Triathlon® Hinge Knee System (2025), 2 descendants of its own
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own
- K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (2025), 0 descendants of its own

## Indications for use
The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions: * There is destruction of the joint surfaces, with or without significant bone deformity * The cruciate and/or collateral ligaments do not stabilize the knee joint * The ligaments are inadequate and/or the musculature is weak and/or * Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components: Indications for use of total knee replacement prostheses include: » noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; » rheumatoid arthritis; » correction of functional deformity; » revision procedures where other treatments or devices have failed; * post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and » irreparable fracture of the knee. Indications for US and Rest of World: Indications for use of total knee replacement prostheses include: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; 5) Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, 6) Irreparable fracture of the knee When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows: The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s): 1) There is destruction of the joint surfaces, with or without significant bone deformity. 2) The cruciate and/or collateral ligaments do not stabilize the knee joint. 3) The ligaments are inadequate and/or the musculature is weak and/or, 4) Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement. MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

Source page: https://510kreport.com/device/K223069
Methodology: https://510kreport.com/methodology