510(k) Report

510(k) · Cleared

Cleared

Modified BMP Trochanteric Plates

K993510510(k) SpecialCleared Nov 16, 199929-day reviewClass II21 CFR 888.3030

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

Biomet, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 16, 1999 after a 29-day review. The FDA summary names no predicate by number. 10 later devices descend from it.

Decided
Nov 16, 1999
Review
29 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2020: 1 descendant cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK993510 Modified BMP Trochanteric PlatesBiomet, Inc. · 1999
  2. Descendant · cites it directly · 9 of its ownK070170 Dall-Miles SystemStryker Orthopaedics · 2007
  3. Descendant · 2 generations on · 8 of its ownK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  4. Descendant · 3 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  5. Descendant · 4 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  6. Descendant · 3 generations on · 1 of its ownK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 12020: 12023: 22024: 22025: 22026: 2
2007high 2 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K070170Dall-Miles SystemStryker Orthopaedics · 2007 · cites it directly9descendants
  • K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · 2 generations on8descendants
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 3 generations on4descendants
  • K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 4 generations on2descendants
  • K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993510Modified BMP Trochanteric PlatesBiomet, Inc.1999—
+1K070170Dall-Miles SystemStryker Orthopaedics2007—
+2K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
202010
202320
202420
202520
202620
FIG. 1 — Lineage of K993510, 1999–2026Source: 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), 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K070170Dall-Miles SystemStryker Orthopaedics20079

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, K070170 (Stryker Orthopaedics, 2007) has gone furthest, with 9 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.

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

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K993510 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993510: Modified BMP Trochanteric Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993510

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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