510(k) Report

510(k) · Cleared

Cleared

Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments

K053505510(k) TraditionalCleared Aug 14, 2006241-day reviewClass II21 CFR 888.3565

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

Biomet Manufacturing, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Aug 14, 2006 as substantially equivalent to K023546 (Biomet, Inc., 2003) and 4 other predicates after a 241-day review. Its family tree reaches back 3 generations to 1998. 19 later devices descend from it.

Decided
Aug 14, 2006
Review
241 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K982302 (1998). 7 ancestors in all, the oldest K915132 (1992). 19 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1992: 1 other ancestor1995: 1 other ancestor2007: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2017: 3 descendants cleared2014: 1 descendant cleared2024: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2019: 2 descendants cleared2021: 3 descendants cleared2025: 2 descendants clearedK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 1998K024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 2 descendants K040487 · Trabecular Metal Knee System Augments · Implex Corp. · 2004 · recalledK024161 · Nexgen Complete Knee Solution - Trabecular Metal Augments · Implex Corp. · 2003 · recalledK982302 · Implex Continuum Knee - Hedrocel Tibial Spacers · Implex Corp. · 19980+5
  1. Root · 3 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
  2. 2 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
  3. 1 generation backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
  4. This deviceK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
  5. Descendant · cites it directly · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
  8. Descendant · 3 generations on · 5 of its ownK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
  9. Descendant · 3 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12011: 12013: 12014: 12015: 12017: 32018: 12019: 22021: 32024: 12025: 2
2007high 3 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all
  • K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · cites it directly13descendants
  • K101994Apex Knee Modular Tibia SystemOmnlife Science · 2010 · 2 generations on6descendants
  • K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · 2 generations on5descendants
  • K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013 · 3 generations on5descendants
  • K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K982302Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp.1998—
−2K024161Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp.20032
−1K040487Trabecular Metal Knee System AugmentsImplex Corp.20041
0 (this device)K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.2006—
+1K080361Regenerex Tibial ComponentsBiomet, Inc.20081
+2K101994Apex Knee Modular Tibia SystemOmnlife Science20101
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.20174
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.2013—
+3K181947Persona Revision Knee SystemZimmer, Inc.20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201110
201310
201410
201510
201730
201810
201920
202130
202410
202520
FIG. 1 — Lineage of K053505, 1998–2025Source: 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · 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? (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
*K023546Maxim Accel Knee System
Summary page 1
…sis, knee, femorotibial, constrained, cemented, metal/polymer (888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System- K023546 (Biomet, Inc.); MCK Knee System- K915132 (Biomet, Inc.); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen…
Biomet, Inc.200313
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…ented, metal/polymer (888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System- K023546 (Biomet, Inc.); MCK Knee System- K915132 (Biomet, Inc.); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen Complete Knee Solution Trabecular Metal-…
Biomet, Inc.19926
*K040487Trabecular Metal Knee System Augments
Summary page 1
…ich Substantial Equivalence Is Claimed: Maxim® Accel Knee System- K023546 (Biomet, Inc.); MCK Knee System- K915132 (Biomet, Inc.); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen Complete Knee Solution Trabecular Metal- K024161 (Zimmer Holdings); Oncology Salvage System- K002757 (B…
Implex Corp.20041
*K024161Nexgen Complete Knee Solution - Trabecular Metal Augments
Summary page 1
…Biomet, Inc.); MCK Knee System- K915132 (Biomet, Inc.); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen Complete Knee Solution Trabecular Metal- K024161 (Zimmer Holdings); Oncology Salvage System- K002757 (Biomet, Inc.) Device Description: The Regenerex TM Ultra Porous Construct- T…
Implex Corp.20032
*K002757Oncology Salvage System
Summary page 1
….); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen Complete Knee Solution Trabecular Metal- K024161 (Zimmer Holdings); Oncology Salvage System- K002757 (Biomet, Inc.) Device Description: The Regenerex TM Ultra Porous Construct- Titanium Knee Augments are designed for attachment to…
Biomet, Inc.200014

Also cleared against K023546: 14 other devices →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080361Regenerex Tibial ComponentsBiomet, Inc.200813
K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074
K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110

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 8 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • Of its descendants, K080361 (Biomet, Inc., 2008) has gone furthest, with 13 descendants of its own.
  • 14 other devices also cite its predicate K023546.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Cemented and uncemented applications The Regenerex T M femoral augments are indicated for use with the VanguardTM Total Knee…

Read the full statement (142 words)

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Cemented and uncemented applications

The Regenerex T M femoral augments are indicated for use with the VanguardTM Total Knee System.

The Regenerex TM tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

4. Ligament deficiencies

5. Tumor Resection

6. Revision of previously failed total joint arthroplasty

7. Trauma

These are single use implants

These devices are for cemented use only

Indications for use as stated in the FDA summary.

Also cleared against K023546

14 other devices cite the same predicate.

  • K183583Vanguard Complete Knee SystemZimmer, Inc. · 2019
  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella…Biomet Manufacturing Corp · 20131 recall
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 20127 recalls
  • K102125Patient-Specific Vanguard Femoral ComponetsBiomet, Inc. · 2011
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

Recent decisions in MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K053505 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053505

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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