# K220142: BRM Digitalis Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Brm Extremities Srl
- Decided: Apr 4, 2023 after 441 days
- Product code: KYJ (Prosthesis, Finger, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970544 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022892: Ascension Sillicone MCP, Ascension Orthopedics, Inc. (2002) Summary page 5.
- K082231: Ascension Silicone Pip, Ascension Orthopedics, Inc. (2009) Summary page 5.
- K870200: Sutter Finger Joint Prosthesis, Sutter Biomedical, Inc. (1987) Summary page 5.
- K931588: Sutter Proximal Interphalangeal Joint, Sutter Corp. (1994) Summary page 5.

## Indications for use
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by: Osteoarthrosis; Rheumatoid arthritis; Post traumatic arthritis. The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by: Rheumatoid arthritis; Osteoarthritis; Ankylosed joints or those with limited range of motion which have not responded to conservative treatment; Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone; Destroyed articular surface(s).

Source page: https://510kreport.com/device/K220142
Methodology: https://510kreport.com/methodology