510(k) Report

510(k) · Cleared

Cleared

Kinematic Rotating Hinge Total Knee PR.

K811630510(k) TraditionalCleared Jul 1, 198122-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

Howmedica Corp. · LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

Cleared on Jul 1, 1981 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Jul 1, 1981
Review
22 days
Class
Class II
Product code
LGE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2025: 2 descendants cleared2023: 3 descendants cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK811630 Kinematic Rotating Hinge Total Knee PR.Howmedica Corp. · 1981
  2. Descendant · cites it directly · 6 of its ownK994207 Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp. · 2000
  3. Descendant · 2 generations on · 4 of its ownK223069 Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  4. Descendant · 2 generations on · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023
  6. Descendant · 2 generations on · 2 of its ownK251665 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2000: 12023: 32025: 22026: 1
2000high 3 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 7 · See all
  • K994207Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp. · 2000 · cites it directly6descendants
  • K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
  • K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
  • K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker · 2023 · 2 generations on3descendants
  • K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K811630Kinematic Rotating Hinge Total Knee PR.Howmedica Corp.1981—
+1K994207Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp.2000—
+2K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+2K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20231
+2K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker2023—
+2K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
202330
202520
202610
FIG. 1 — Lineage of K811630, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K994207Howmedica Osteonics Modular Rotating Hinge KneeHowmedica Osteonics Corp.20006

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, K994207 (Howmedica Osteonics Corp., 2000) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LGE devices

LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGE

FDA has decided no LGE device since 2007.

Median 510(k) review, days · LGE

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

Recalls per year · LGE

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · LGE

1in 2023

2007: 12010: 72011: 12012: 22014: 52015: 22018: 22023: 1
2007high 7 (2010) · low 0 (2008)2025

MAUDE reports naming product code LGE, 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—01
20080—00
20090—00
20100—07
20110—01
20120—02
20130—00
20140—05
20150—02
20160—00
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—1—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in LGE

The LGE category page

  • K992346Kinematic II Rotating Hinge KneeHowmedica Osteonics Corp. · 1999

https://510kreport.com/device/K811630 · printed Nov 5, 2026

Cite this page

510(k) Report. “K811630: Kinematic Rotating Hinge Total Knee PR..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K811630

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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