510(k) Report

510(k) · Cleared

Cleared

Sutter Proximal Interphalangeal Joint

K931588510(k) TraditionalCleared Mar 10, 1994344-day reviewClass II21 CFR 888.3230

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sutter Corp. · KYJ Prosthesis, Finger, Constrained, Polymer

Cleared on Mar 10, 1994 after a 344-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 10, 1994
Review
344 days
Class
Class II
Product code
KYJ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared1990200020102020
  1. This deviceK931588 Sutter Proximal Interphalangeal JointSutter Corp. · 1994
  2. Descendant · cites it directly · 0 of its ownK220142 BRM Digitalis SpacerBrm Extremities Srl · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K220142BRM Digitalis SpacerBrm Extremities Srl · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931588Sutter Proximal Interphalangeal JointSutter Corp.1994—
+1K220142BRM Digitalis SpacerBrm Extremities Srl2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K931588, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K233670 Ascension Silicone MCP; Ascension Silicone PIPscore 7.1 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K220142BRM Digitalis SpacerBrm Extremities Srl20230

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?

  • Of its descendants, K220142 (Brm Extremities Srl, 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KYJ devices

KYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYJ

2in 2023

2009: 22015: 12022: 12023: 2
2007high 2 (2009) · low 0 (2007)2026

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

2016: 22019: 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KYJ

32in 2025

2007: 92008: 152009: 352010: 92011: 112012: 252013: 112014: 142015: 182016: 62017: 142018: 112019: 262020: 482021: 452022: 392023: 242024: 292025: 32
2007high 48 (2020) · low 6 (2016)2025

MAUDE reports naming product code KYJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—09
20080—015
20092—035
20100—09
20110—011
20120—025
20130—011
20140—014
20151—018
20160—26
20170—014
20180—011
20190—126
20200—048
20210—045
20221—039
20232—024
20240—029
20250—032
20260—0—

More from Sutter Corp.

7 FDA decisions under this applicant name. See the company

  • K943354Sutter Hammertoe Joint ProsthesisSutter Corp. · 1995
  • K945221Sutter Model 6000 Hand CPM DeviceSutter Corp. · 1995
  • K924654First Metatarsophalangeal Joint Motion SplintSutter Corp. · 1993
  • K914860Sutter Model 10000 Leg CPM DeviceSutter Corp. · 1992
  • K902707Model 9000 at Ankle CPM DeviceSutter Corp. · 1990

Recent decisions in KYJ

The KYJ category page

  • K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
  • K220142BRM Digitalis SpacerBrm Extremities Srl · 2023
  • K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022
  • K140453Osteotec Silicone Finger ImplantOsteotec, Ltd. · 20151 recall
  • K083107Modification to Depuy Neuflex Pip FingerDePuy Orthopaedics, Inc. · 2009

https://510kreport.com/device/K931588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931588: Sutter Proximal Interphalangeal Joint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931588

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026