510(k) Report

510(k) · Cleared

Cleared

Whiteside Ortholoc (TM)

K864070510(k) TraditionalCleared Jan 27, 198799-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

Dow Corning Wright · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Jan 27, 1987 after a 99-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
Jan 27, 1987
Review
99 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2024: 1 descendant cleared1990200020102020
  1. This deviceK864070 Whiteside Ortholoc (TM)Dow Corning Wright · 1987
  2. Descendant · cites it directly · 0 of its ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864070Whiteside Ortholoc (TM)Dow Corning Wright1987—
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal…Microport Orthopedics, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K864070, 1987–2024Source: 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240

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, K240043 (Microport Orthopedics, Inc., 2024) has gone furthest, with 0 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—

More from Dow Corning Wright

75 FDA decisions under this applicant name. See the company

  • K932210Ortholoc Advantim Revision Femoral ComponentDow Corning Wright · 1994
  • K932911Ortholoc Advantim L.S. Tibial ComponentDow Corning Wright · 1994
  • K934354Lacey All Polyethylene Tibial ComponentDow Corning Wright · 1994
  • K932222SLT Femoral HeadDow Corning Wright · 1994
  • K932858Ortholoc Advantim Tibial Base ComponentDow Corning Wright · 1994

Recent decisions in HRY

The HRY category page

  • K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
  • K190633NanoOrtho NanoKnee® SystemNanoortho, LLC · 2019
  • K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 20144 recalls

https://510kreport.com/device/K864070 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864070: Whiteside Ortholoc (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864070

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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