510(k) Report

510(k) · Cleared

Cleared

BHR Bipolar Femoral Head Component

K915528510(k) TraditionalCleared Jun 29, 1993567-day reviewClass II21 CFR 888.3360

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

Implantology Corp. · LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Cleared on Jun 29, 1993 after a 567-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 29, 1993
Review
567 days
Class
Class II
Product code
LZY
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915528Source: FDA 510(k) database · 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 LZY? 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 LZY device

  1. #1 K231448 TANDEM Hip Systemscore 6.4 · 10 generations · no Class I recall
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LZY devices

LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZY

1in 2023

2011: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZY

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

Recalls per year · LZY

1in 2025

2009: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LZY

74in 2025

2007: 92008: 262009: 202010: 382011: 432012: 462013: 442014: 462015: 972016: 762017: 722018: 672019: 592020: 792021: 592022: 652023: 772024: 742025: 74
2007high 97 (2015) · low 9 (2007)2025

MAUDE reports naming product code LZY, 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—09
20080—026
20090—120
20100—038
20111—043
20120—046
20130—044
20140—046
20150—097
20160—076
20170—072
20180—067
20190—059
20200—079
20210—059
20220—065
20231—077
20240—074
20250—174
20260—0—

More from Implantology Corp.

9 FDA decisions under this applicant name. See the company

  • K934729Ufc Hip Stem Components: Hydroxylapatite CoatedImplantology Corp. · 1994
  • K915529FPC/SFPC/RFPC Acetabular ComponentImplantology Corp. · 1993
  • K915527CPS Acetabular ComponentImplantology Corp. · 1993
  • K915385PPC Hip Stem ComponentImplantology Corp. · 1993
  • K924099Ufc Hip Stem ComponentImplantology Corp. · 1993

Recent decisions in LZY

The LZY category page

  • K231448TANDEM Hip SystemSmith & Nephew, Inc. · 20231 recall
  • K111145Endo HeadMedacta International · 2011
  • K974442Pre-Powdered Nitrile Examination GlovesP.T. Latexindo Tobaperkasa · 1998
  • K915548Ionguard Titanium Modular HeadsBiomet, Inc. · 1992
  • K903084Modular Cathcart Fracture SystemDepuy, Inc. · 19901 recall

https://510kreport.com/device/K915528 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915528: BHR Bipolar Femoral Head Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915528

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