# K033242: Knee Interpositional Mini-Repair System (Kimrs)

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Therapeutics, Inc.
- Decided: Dec 31, 2003 after 85 days
- Product code: HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented))
- Device class: 2
- Regulation: 21 CFR 888.3590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911802 (1992). 5 ancestors in all.
65 later devices descend from it; 5 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964395: Patient Specific Implant (Psi) Hip Femoral Component, Hayes Medical, Inc. (1997) Summary page 2.
- K911802: Pmi (Patient Matched Implants) Hip Femoral Comp, Biomet, Inc. (1992) Summary page 2.
- K911058: Techmedica Cad/Cam Custom Hip, Techmedica, Inc. (1993) Summary page 2.
- K003269: Unicondylar Interpositional Spacer, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- K022779: Oti Unicondular Interpositional Spacer, Osteoimplant Technology, Inc. (2002) Summary page 2.
- (no number) McKeever Hemiarthroplasty Prosthesis: named in the summary without a submission number

## Most influential descendants
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), 62 descendants of its own
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 40 descendants of its own
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 38 descendants of its own

## Indications for use
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following: Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments. The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.

Source page: https://510kreport.com/device/K033242
Methodology: https://510kreport.com/methodology