510(k) · Cleared
ClearedBRM Digitalis Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brm Extremities Srl · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Apr 4, 2023 as substantially equivalent to K022892 (Ascension Orthopedics, Inc., 2002) and 3 other predicates after a 441-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Apr 4, 2023
- Review
- 441 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K970544 (1997). 6 ancestors in all, the oldest K870200 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK970544 Depuy Dupont Orthopaedics Finger Joint ProsthesisDepuy, Inc. · 1997
- 2 generations backK001922 Depuy Neuflex Pip FingerDepuy, Inc. · 2000
- 1 generation backK082231 Ascension Silicone PipAscension Orthopedics, Inc. · 2009 · Recalled
- This deviceK220142 BRM Digitalis SpacerBrm Extremities Srl · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970544 | Depuy Dupont Orthopaedics Finger Joint Prosthesis | Depuy, Inc. | 1997 | — |
| −2 | K001922 | Depuy Neuflex Pip Finger | Depuy, Inc. | 2000 | — |
| −1 | K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | 2009 | 1 |
| 0 (this device) | K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KYJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KYJ device
- #1 K233670 Ascension Silicone MCP; Ascension Silicone PIPscore 7.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022892 | Ascension Sillicone MCPSummary page 5…d base of the medial phalanx. Primary Predicate Device: The Digitalis Spacer is substantially equivalent to the primary predicate device Ascension Silicone MCP Spacers (K022892) with respect to intended use and indications for use, similar dimensions, and geometry. Additional Predicate Devices: The Digit… | 2002 |
| * | K082231 | Ascension Silicone PipSummary page 5…ilar dimensions, and geometry. Additional Predicate Devices: The Digitalis Spacer is substantially equivalent to the additional predicate devices Ascension PIP Spacers (K082231) and Stryker Silicone PIP & MCP (K870200 & K931588) with respect to intended use and indications for use, similar dimensions, and… | 2009 |
| * | K870200 | Sutter Finger Joint ProsthesisSummary page 5…l Predicate Devices: The Digitalis Spacer is substantially equivalent to the additional predicate devices Ascension PIP Spacers (K082231) and Stryker Silicone PIP & MCP (K870200 & K931588) with respect to intended use and indications for use, similar dimensions, and geometry. Reference Device: The Digital… | 1987 |
| * | K931588 | Sutter Proximal Interphalangeal JointSummary page 5…e Devices: The Digitalis Spacer is substantially equivalent to the additional predicate devices Ascension PIP Spacers (K082231) and Stryker Silicone PIP & MCP (K870200 & K931588) with respect to intended use and indications for use, similar dimensions, and geometry. Reference Device: The Digitalis Spacer… | 1994 |
| † | K191966 | NewPrim System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K022892.
How does its category compare?
All KYJ devicesKYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KYJ
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KYJ
Too few KYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KYJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYJ
32in 2025
MAUDE reports naming product code KYJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 35 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 0 | — | 2 | 6 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 1 | 26 |
| 2020 | 0 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 45 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 2 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220142: BRM Digitalis Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220142
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026