510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Modular Protusio Cup

K990032510(k) TraditionalCleared Feb 18, 199943-day reviewClass II21 CFR 888.3350Recalls 1

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 18, 1999 as substantially equivalent to K911718 (Biomet, Inc., 1991) and 4 other predicates after a 43-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it. It has been recalled once.

Decided
Feb 18, 1999
Review
43 days
Class
Class II
Product code
JDI
Recalls
1
Predicates
5

Its longest line of descent runs back 3 generations to K953578 (1995). 7 ancestors in all, the oldest K911718 (1991). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1996: 1 other ancestor2000: 1 descendant clearedK953578 · Protek Acetabular Roof Reinforcement Ring · Intermedics Orthopedics · 1995K960678 · Burch/Schneider Reinforcement Cage · Intermedics Orthopedics · 1996K971890 · Recovery Protrusio Cage · Biomet, Inc. · 1997 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K971890 · Recovery Protrusio Cage · Biomet, Inc. · 1997 · recalledK960678 · Burch/Schneider Reinforcement Cage · Intermedics Orthopedics · 1996K953578 · Protek Acetabular Roof Reinforcement Ring · Intermedics Orthopedics · 19950
  1. Root · 3 generations backK953578 Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics · 1995
  2. 2 generations backK960678 Burch/Schneider Reinforcement CageIntermedics Orthopedics · 1996
  3. 1 generation backK971890 Recovery Protrusio CageBiomet, Inc. · 1997 · Recalled
  4. This deviceK990032 Modular Protusio CupBiomet, Inc. · 1999
  5. Descendant · cites it directly · 0 of its ownK992359 MRS-TitanRotec Medizintechnik GmbH · 2000

Most influential descendants

Showing 1 of 1 · See all
  • K992359MRS-TitanRotec Medizintechnik GmbH · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953578Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics1995—
−2K960678Burch/Schneider Reinforcement CageIntermedics Orthopedics1996—
−1K971890Recovery Protrusio CageBiomet, Inc.19971
0 (this device)K990032Modular Protusio CupBiomet, Inc.1999—
+1K992359MRS-TitanRotec Medizintechnik GmbH2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K990032, 1995–2000Source: 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
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
*K911718M.a.R.a. (Modular Acetabular Reconstruction Syst)
Summary page 2
…in overall design and intended function. The following devices are predicates to the Modular Protrusio Cup: Biomet’s Modular Acetabular Reconstructive System (M.A.R.S) (K911718), Biomet’s Healy Revision Component System (K921139), Biomet’s Recovery protrusio Cage (K971890), Osteonics’ Restoration GAP Acet…
Biomet, Inc.1991—
*K921139Healey Revision Component System
Summary page 2
…ing devices are predicates to the Modular Protrusio Cup: Biomet’s Modular Acetabular Reconstructive System (M.A.R.S) (K911718), Biomet’s Healy Revision Component System (K921139), Biomet’s Recovery protrusio Cage (K971890), Osteonics’ Restoration GAP Acetabular Cup (K943549), and Intermedics’ Orthopaedics’…
Biomet, Inc.1992—
*K971890Recovery Protrusio Cage
Summary page 2
…otrusio Cup: Biomet’s Modular Acetabular Reconstructive System (M.A.R.S) (K911718), Biomet’s Healy Revision Component System (K921139), Biomet’s Recovery protrusio Cage (K971890), Osteonics’ Restoration GAP Acetabular Cup (K943549), and Intermedics’ Orthopaedics’ Burch/Schneider Reinforcement Cage (K960678…
Biomet, Inc.19971
*K943549Restoration Acetabular Cup
Summary page 2
…ve System (M.A.R.S) (K911718), Biomet’s Healy Revision Component System (K921139), Biomet’s Recovery protrusio Cage (K971890), Osteonics’ Restoration GAP Acetabular Cup (K943549), and Intermedics’ Orthopaedics’ Burch/Schneider Reinforcement Cage (K960678). 00065 *” “l"c""b & <, _5 -/é DEP…
Osteonics Corp.1994—
*K960678Burch/Schneider Reinforcement Cage
Summary page 2
…139), Biomet’s Recovery protrusio Cage (K971890), Osteonics’ Restoration GAP Acetabular Cup (K943549), and Intermedics’ Orthopaedics’ Burch/Schneider Reinforcement Cage (K960678). 00065 *” “l"c""b & <, _5 -/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 3 %, o Food and Dru…
Intermedics Orthopedics1996—

Also cleared against K911718: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K992359MRS-TitanRotec Medizintechnik GmbH20000

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2020Class IIZ-0627-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K992359 (Rotec Medizintechnik GmbH, 2000) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K911718.

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?

The indications for the Modular Protrusio Cup are as follows:

1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2) Rheumatoid arthritis

3) Correction of functional deformity

4) Treatment of nonunion, femoral neck fractures, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

5) Revision of failed joint construction or treatment

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

Also cleared against K911718

1 other device cites the same predicate.

  • K992359MRS-TitanRotec Medizintechnik GmbH · 2000

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/K990032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990032: Modular Protusio Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990032

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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