510(k) Report

510(k) · Cleared

Cleared

Lesser Metatarsal Phalang. Joint Prosth

K820813510(k) TraditionalCleared May 21, 198259-day reviewClass II21 CFR 888.3720

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

Sutter Biomedical, Inc. · KWH Prosthesis, Toe, Constrained, Polymer

Cleared on May 21, 1982 after a 59-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
May 21, 1982
Review
59 days
Class
Class II
Product code
KWH
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared19801990200020102020
  1. This deviceK820813 Lesser Metatarsal Phalang. Joint ProsthSutter Biomedical, Inc. · 1982
  2. Descendant · cites it directly · 2 of its ownK023531 Lesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK173491 RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
  4. Descendant · 3 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019

Most influential descendants

Showing 3 of 3 · See all
  • K023531Lesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc. · 2003 · cites it directly2descendants
  • K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018 · 2 generations on1descendant
  • K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820813Lesser Metatarsal Phalang. Joint ProsthSutter Biomedical, Inc.1982—
+1K023531Lesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc.20031
+2K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC2018—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System…In2bones USA, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201810
201910
FIG. 1 — Lineage of K820813, 1982–2019Source: 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 KWH? 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 KWH device

  1. #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
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)

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

NumberDeviceApplicantDecidedDescendants
K023531Lesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc.20032

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, K023531 (Nexa Orthopedics, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KWH devices

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

FDA decisions per year · KWH

1in 2020

2011: 12016: 12018: 12019: 12020: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWH

Too few KWH 510(k)s in any year since 2007 to give a median.

Recalls per year · KWH

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KWH

8in 2025

2007: 22008: 42009: 52010: 32011: 22012: 62013: 52014: 62015: 62016: 62017: 32018: 72019: 152020: 82021: 52022: 52023: 62024: 22025: 8
2007high 15 (2019) · low 2 (2007)2025

MAUDE reports naming product code KWH, 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—02
20080—04
20090—25
20100—03
20111—02
20120—06
20130—05
20140—06
20150—06
20161—06
20170—03
20181—07
20191—015
20201—08
20210—05
20220—05
20230—06
20240—02
20250—08
20260—0—

More from Sutter Biomedical, Inc.

11 FDA decisions under this applicant name. See the company

  • K875249Sutter Phalangeal CapSutter Biomedical, Inc. · 1988
  • K870200Sutter Finger Joint ProsthesisSutter Biomedical, Inc. · 1987
  • K861983Sutter Lesser Metatarsal CapSutter Biomedical, Inc. · 1986
  • K850274Sutter CPM 9000 -Nonmeasuring Exercise EquipmentSutter Biomedical, Inc. · 1985
  • K830974Sutter CPM 5000Sutter Biomedical, Inc. · 1983

Recent decisions in KWH

The KWH category page

  • K191966NewPrim SystemBrm Extremities · 2020
  • K190136Fusion Silastic SystemFusion Orthopedics, LLC · 2019
  • K173491RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
  • K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
  • K102601Orthoflex RodOrtho-Pro, LLC · 2011

https://510kreport.com/device/K820813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820813: Lesser Metatarsal Phalang. Joint Prosth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820813

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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