510(k) Report

510(k) · Cleared

Cleared

Bipolar Femoral Head

K981238510(k) TraditionalCleared Aug 21, 1998140-day reviewClass II21 CFR 888.3390

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

Whiteside Biomechanics, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Cleared on Aug 21, 1998 after a 140-day review. The FDA summary names no predicate by number. 7 later devices descend from it.

Decided
Aug 21, 1998
Review
140 days
Class
Class II
Product code
KWY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981238 Bipolar Femoral HeadWhiteside Biomechanics, Inc. · 1998
  2. Descendant · cites it directly · 6 of its ownK050269 U1 Hip System - BipolarUnited Orthopedic Corp. · 2005
  3. Descendant · 2 generations on · 5 of its ownK101670 United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
  5. Descendant · 3 generations on · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
  6. Descendant · 4 generations on · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12010: 12013: 12016: 12017: 12018: 12022: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K050269U1 Hip System - BipolarUnited Orthopedic Corp. · 2005 · cites it directly6descendants
  • K101670United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010 · 2 generations on5descendants
  • K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016 · 2 generations on3descendants
  • K162957U2 Femoral HeadUnited Orthopedic Corporation · 2017 · 3 generations on1descendant
  • K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981238Bipolar Femoral HeadWhiteside Biomechanics, Inc.1998—
+1K050269U1 Hip System - BipolarUnited Orthopedic Corp.2005—
+2K101670United U2 Bipolar ImplantUnited Orthopedic Corp.20101
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation2016—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation2017—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201010
201310
201610
201710
201810
202210
FIG. 1 — Lineage of K981238, 1998–2022Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWY? 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 KWY device

  1. #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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?

The FDA summary names no predicate by number.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K050269U1 Hip System - BipolarUnited Orthopedic Corp.20056

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, K050269 (United Orthopedic Corp., 2005) has gone furthest, with 6 descendants of its own.

How does its category compare?

All KWY devices

KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWY

1in 2025

2008: 32009: 12010: 42011: 12012: 12013: 22014: 12015: 12016: 12017: 12018: 32019: 52020: 12022: 22023: 22025: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWY

126in 2019

2008: 123 days median2010: 187 days median2018: 219 days median2019: 126 days median
2007high 219 (2018) · low 123 (2008)2026

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

Recalls per year · KWY

2in 2025

2007: 252009: 242010: 12012: 12013: 22016: 32017: 22018: 12019: 12024: 12025: 2
2007high 25 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWY

180in 2025

2007: 3702008: 9002009: 9612010: 6882011: 7582012: 9782013: 1,1482014: 1,0552015: 1,2132016: 8772017: 8262018: 1,3802019: 1,5302020: 1,2592021: 2762022: 2082023: 1782024: 2092025: 180
2007high 1,530 (2019) · low 178 (2023)2025

MAUDE reports naming product code KWY, 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—25370
200831230900
20091—24961
201041871688
20111—0758
20121—1978
20132—21,148
20141—01,055
20151—01,213
20161—3877
20171—2826
2018321911,380
2019512611,530
20201—01,259
20210—0276
20222—0208
20232—0178
20240—1209
20251—2180
20261—0—

What is it indicated for?

1. Noninflammatory degenerative joint disease

including osteoarthritis.

2. Avascular necrosis.

3. Correction of functional deformity.

4. Revision procedures where other treatments

or devices have failed.

5. Treatment of femoral neck and trochanteric

fractures of the proximal femur with head

involvement and non-union of femoral neck

fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Whiteside Biomechanics, Inc.

13 FDA decisions under this applicant name. See the company

  • K033313Quatro M Femoral ComponentWhiteside Biomechanics, Inc. · 2004
  • K012800Symmetric Unicompartmental Knee SystemWhiteside Biomechanics, Inc. · 2002
  • K003618Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model Bio-1-1014Whiteside Biomechanics, Inc. · 2001
  • K993903Whiteside Biomechanics Titanium Low-Profile Cable, Model Bio-1-1013Whiteside Biomechanics, Inc. · 2000
  • K991678Whiteside Biomechanics Spinal SystemWhiteside Biomechanics, Inc. · 1999

Recent decisions in KWY

The KWY category page

  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc. · 2025
  • K231526CORAIL Cemented Femoral StemDepuy Ireland UC · 2023
  • K223441SpaceFlex Acetabular CupG21, S.R.L. · 2023
  • K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG · 2022

https://510kreport.com/device/K981238 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981238: Bipolar Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981238

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026