# K022779: Oti Unicondular Interpositional Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Nov 20, 2002 after 90 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
No predicates in its family tree.
66 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033242: Knee Interpositional Mini-Repair System (Kimrs) (2003), 65 descendants of its own
- 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

## Indications for use
The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amouizts of articular cartlige have been lost as a result of the disease. The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following: Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia) and minimal degeneration (grade I-11 chondromalacia, no loss of joint space) in the patellofemoral components.

Source page: https://510kreport.com/device/K022779
Methodology: https://510kreport.com/methodology