510(k) Report

510(k) · Cleared

Cleared

Apf Porous Coated Line Extension

K984154510(k) TraditionalCleared Feb 11, 199984-day reviewClass II21 CFR 888.3350

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

Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Feb 11, 1999 as substantially equivalent to K852585 (Biomet, Inc., 1985) and 4 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1994.

Decided
Feb 11, 1999
Review
84 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K941847 (1994). 9 ancestors in all, the oldest K852585 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1994: 3 other ancestors1985: 1 other ancestor1996: 1 other ancestorK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 19971985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 19940
  1. Root · 2 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 1 generation backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. This deviceK984154 Apf Porous Coated Line ExtensionBiomet, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−1K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
0 (this device)K984154Apf Porous Coated Line ExtensionBiomet, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199430
199610
199710
FIG. 1 — Lineage of K984154, 1994–1999Source: 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), 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K852585Porous Apf/Modular Femoral Component
Summary page 2
…F Porous Coated Line Extension is equivalent to other commercially available hip stems currently on the market. These devices include: Porous APF (Biomet, Inc. — 510(k) K852585) Integral Hip Stem (Biomet, Inc. — 510(k) K921225) Reach Femoral Stem (Biomet, Inc. — 510(k) K971824) AML (DePuy — 510(k) K964…
Biomet, Inc.1985—
*K921225Integral Total Hip System
Summary page 2
…er commercially available hip stems currently on the market. These devices include: Porous APF (Biomet, Inc. — 510(k) K852585) Integral Hip Stem (Biomet, Inc. — 510(k) K921225) Reach Femoral Stem (Biomet, Inc. — 510(k) K971824) AML (DePuy — 510(k) K964650) The Solution System (DePuy — 510(k) K941942)…
Biomet, Inc.1994—
*K971824Reach Femoral Hip Component
Summary page 2
…market. These devices include: Porous APF (Biomet, Inc. — 510(k) K852585) Integral Hip Stem (Biomet, Inc. — 510(k) K921225) Reach Femoral Stem (Biomet, Inc. — 510(k) K971824) AML (DePuy — 510(k) K964650) The Solution System (DePuy — 510(k) K941942) Information on these predicate devices and a table p…
Biomet, Inc.1997—
*K964650TCP-Coated Porocoat Aml Femoral Hip Prosthesis
Summary page 2
…: Porous APF (Biomet, Inc. — 510(k) K852585) Integral Hip Stem (Biomet, Inc. — 510(k) K921225) Reach Femoral Stem (Biomet, Inc. — 510(k) K971824) AML (DePuy — 510(k) K964650) The Solution System (DePuy — 510(k) K941942) Information on these predicate devices and a table providing comparison is contain…
Depuy, Inc.1997—
*K941942Solution Hip
Summary page 2
…Integral Hip Stem (Biomet, Inc. — 510(k) K921225) Reach Femoral Stem (Biomet, Inc. — 510(k) K971824) AML (DePuy — 510(k) K964650) The Solution System (DePuy — 510(k) K941942) Information on these predicate devices and a table providing comparison is contained in Exhibit IV. 00114 o sll…
Depuy, Inc.1994—

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.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • None of the 8 ancestors has a recall.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

Biomet’s APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.

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 JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K984154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984154: Apf Porous Coated Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984154

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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