510(k) Report

510(k) · Cleared

Cleared

Biocore9 Acetabular Cup System

K212761510(k) TraditionalCleared May 17, 2022259-day reviewClass II21 CFR 888.3358

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

Biocore9, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 17, 2022 as substantially equivalent to K842202 (Endomedics, Inc., 1984) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 1984.

Decided
May 17, 2022
Review
259 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K842202 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1988: 1 other ancestorReference device: K033273 · Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads · DePuy Orthopaedics, Inc. · 2004Reference device: K182468 · Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019Reference device: K151264 · Restoration Anatomic Shell · Stryker Orthopaedics · 2015 · recalledReference device: K062148 · Depuy Pinnacle Altrx Acetabular Cup Liner · DePuy Orthopaedics, Inc. · 2006Reference device: K201219 · Biocore9 Femoral Head Resurfacing Component · Biocore9, LLC · 2021Reference device: K193122 · Biocore9 Humeral Resurfacing System · Biocore9, LLC · 2020K842202 · New Jersey Acetabular Component & · Endomedics, Inc. · 198419801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor K842202 · New Jersey Acetabular Component & · Endomedics, Inc. · 19840
  1. Root · 1 generation backK842202 New Jersey Acetabular Component &Endomedics, Inc. · 1984
  2. This deviceK212761 Biocore9 Acetabular Cup SystemBiocore9, LLC · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K842202New Jersey Acetabular Component &Endomedics, Inc.1984—
0 (this device)K212761Biocore9 Acetabular Cup SystemBiocore9, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
FIG. 1 — Lineage of K212761, 1984–2022Source: 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (2)

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
*K842202New Jersey Acetabular Component &
Summary page 4
…constrained cemented prosthesis Device Product Codes: LPH, JDI Primary Predicate Device: K842202 Endomedics Inc. Acetabular Cup and screw Additional Predicate Devices: K884888 Protek Inc. Modified New Jersey Acet…
Endomedics, Inc.1984—
*K884888Modified New Jersey Acetabular Comp. & Bone Screws
Summary page 4
…es: LPH, JDI Primary Predicate Device: K842202 Endomedics Inc. Acetabular Cup and screw Additional Predicate Devices: K884888 Protek Inc. Modified New Jersey Acetabular component &bone screws Reference Devices:…
Protek, Inc.1988—
†K033273Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…DePuy Orthopaedics, Inc.2004—
†K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
†K151264Restoration Anatomic ShellStryker Orthopaedics201517
†K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006—
†K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC2021—
†K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC2020—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis. 2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement. 3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient The Biocore9 Acetabular Cup…

Read the full statement (97 words)

1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis.

2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement.

3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient

The Biocore9 Acetabular Cup System components are intended for use in total hip arthroplasty in primary or revision surgery of skeletally mature patients. The Biocore9 Acetabular Cup System shells and liners are single use implants intended for cemented or cementless arthroplasty.

Indications for use as stated in the FDA summary.

More from Biocore9, LLC

3 FDA decisions under this applicant name. See the company

  • K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC · 2021
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K212761 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212761: Biocore9 Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212761

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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