510(k) Report

510(k) · Cleared

Cleared

Prosthesis, Richards Mod II Knee

K760245510(k) TraditionalCleared Jul 26, 19767-day reviewClass II21 CFR 888.3530

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

Richard'S Medical Equip., Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jul 26, 1976 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Jul 26, 1976
Review
7 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2012: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK760245 Prosthesis, Richards Mod II KneeRichard'S Medical Equip., Inc. · 1976
  2. Descendant · cites it directly · 5 of its ownK061779 Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc. · 2006
  3. Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  5. Descendant · 3 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
  6. Descendant · 3 generations on · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12012: 12023: 12024: 22026: 1
2006high 2 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K061779Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc. · 2006 · cites it directly5descendants
  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 3 generations on0descendants
  • K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 3 generations on0descendants
  • K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760245Prosthesis, Richards Mod II KneeRichard'S Medical Equip., Inc.1976—
+1K061779Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc.2006—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…Smith & Nephew, Inc.20231
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.2026—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201210
202310
202420
202610
FIG. 1 — Lineage of K760245, 1976–2026Source: 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 HRY? 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 HRY device

  1. #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 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? (6)

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

NumberDeviceApplicantDecidedDescendants
K061779Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc.20065

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, K061779 (Smith & Nephew, Inc., 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All HRY devices

HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRY

1in 2020

2007: 32008: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRY

138in 2008

2007: 92 days median2008: 138 days median
2007high 138 (2008) · low 92 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRY

3in 2022

2007: 12008: 12011: 12013: 12016: 12020: 12021: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

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

Adverse event reports per year · HRY

290in 2025

2007: 2632008: 2852009: 2492010: 1802011: 1552012: 1372013: 3832014: 3052015: 3452016: 3432017: 4022018: 6132019: 3672020: 1,0542021: 1,2182022: 8402023: 3962024: 4302025: 290
2007high 1,218 (2021) · low 137 (2012)2025

MAUDE reports naming product code HRY, 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
20073921263
200831381285
20090—0249
20101—0180
20111—1155
20121—0137
20131—1383
20141—0305
20151—0345
20161—1343
20170—0402
20180—0613
20191—0367
20201—11,054
20210—11,218
20220—3840
20230—0396
20240—0430
20250—0290
20260—0—
Cite this page

510(k) Report. “K760245: Prosthesis, Richards Mod II Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760245

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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