510(k) Report

510(k) · Cleared

Cleared

Sutter Finger Joint Prosthesis

K870200510(k) TraditionalCleared Oct 9, 1987262-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 Biomedical, Inc. · KYJ Prosthesis, Finger, Constrained, Polymer

Cleared on Oct 9, 1987 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 9, 1987
Review
262 days
Class
Class II
Product code
KYJ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2023: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK870200 Sutter Finger Joint ProsthesisSutter Biomedical, Inc. · 1987
  2. Descendant · cites it directly · 1 of its ownK013629 Finger Joint ProsthesisAvanta Orthopaedics, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK220142 BRM Digitalis SpacerBrm Extremities Srl · 2023
  4. Descendant · 2 generations on · 0 of its ownK140453 Osteotec Silicone Finger ImplantOsteotec, Ltd. · 2015 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K013629Finger Joint ProsthesisAvanta Orthopaedics, Inc. · 2002 · cites it directly1descendant
  • K220142BRM Digitalis SpacerBrm Extremities Srl · 2023 · cites it directly0descendants
  • K140453Osteotec Silicone Finger ImplantOsteotec, Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870200Sutter Finger Joint ProsthesisSutter Biomedical, Inc.1987—
+1K013629Finger Joint ProsthesisAvanta Orthopaedics, Inc.2002—
+1K220142BRM Digitalis SpacerBrm Extremities Srl2023—
+2K140453Osteotec Silicone Finger ImplantOsteotec, Ltd.20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201510
202310
FIG. 1 — Lineage of K870200, 1987–2023Source: 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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013629Finger Joint ProsthesisAvanta Orthopaedics, Inc.20021
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, K013629 (Avanta Orthopaedics, Inc., 2002) has gone furthest, with 1 descendant 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 Biomedical, Inc.

11 FDA decisions under this applicant name. See the company

  • K875249Sutter Phalangeal CapSutter Biomedical, Inc. · 1988
  • K861983Sutter Lesser Metatarsal CapSutter Biomedical, Inc. · 1986
  • K850274Sutter CPM 9000 -Nonmeasuring Exercise EquipmentSutter Biomedical, Inc. · 1985
  • K830974Sutter CPM 5000Sutter Biomedical, Inc. · 1983
  • K830649Sutter CPM 2000Sutter Biomedical, Inc. · 1983

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/K870200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870200: Sutter Finger Joint Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870200

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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