510(k) Report

510(k) · Cleared

Cleared

MRS-Titan

K992359510(k) TraditionalCleared Feb 18, 2000219-day reviewClass II21 CFR 888.3353

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

Rotec Medizintechnik GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Feb 18, 2000 as substantially equivalent to K963946 (Osteonics Corp., 1997) and 3 other predicates after a 219-day review. Its family tree reaches back 4 generations to 1995.

Decided
Feb 18, 2000
Review
219 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K953578 (1995). 9 ancestors in all, the oldest K911718 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1991: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestorK953578 · Protek Acetabular Roof Reinforcement Ring · Intermedics Orthopedics · 1995K960678 · Burch/Schneider Reinforcement Cage · Intermedics Orthopedics · 1996K971890 · Recovery Protrusio Cage · Biomet, Inc. · 1997 · recalledK990032 · Modular Protusio Cup · Biomet, Inc. · 1999 · recalled1990199219941996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors K990032 · Modular Protusio Cup · Biomet, Inc. · 1999 · recalledK971890 · Recovery Protrusio Cage · Biomet, Inc. · 1997 · recalledK960678 · Burch/Schneider Reinforcement Cage · Intermedics Orthopedics · 1996K953578 · Protek Acetabular Roof Reinforcement Ring · Intermedics Orthopedics · 19950
  1. Root · 4 generations backK953578 Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics · 1995
  2. 3 generations backK960678 Burch/Schneider Reinforcement CageIntermedics Orthopedics · 1996
  3. 2 generations backK971890 Recovery Protrusio CageBiomet, Inc. · 1997 · Recalled
  4. 1 generation backK990032 Modular Protusio CupBiomet, Inc. · 1999 · Recalled
  5. This deviceK992359 MRS-TitanRotec Medizintechnik GmbH · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K953578Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics1995—
−3K960678Burch/Schneider Reinforcement CageIntermedics Orthopedics1996—
−2K971890Recovery Protrusio CageBiomet, Inc.19971
−1K990032Modular Protusio CupBiomet, Inc.19991
0 (this device)K992359MRS-TitanRotec Medizintechnik GmbH2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199410
199610
199710
FIG. 1 — Lineage of K992359, 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (4)

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
*K963946Osteonics Modular Acetabular Cup (Microstructured Version)
Summary page 3
…ivalent to other acetabular devices on the market in our design and intended function. The following devices are predicated to the MRS-Titan: Osteonics restauration gap, K963946, Biomeds modular acetabular reconstructive system, K 911718, Biomeds recovery protrusio cup, K 971890, Osteonics modular acetabul…
Osteonics Corp.1997—
*K911718M.a.R.a. (Modular Acetabular Reconstruction Syst)
Summary page 3
…sign and intended function. The following devices are predicated to the MRS-Titan: Osteonics restauration gap, K963946, Biomeds modular acetabular reconstructive system, K 911718, Biomeds recovery protrusio cup, K 971890, Osteonics modular acetabular cup, microstructured version, K 963946, Biomeds modular p…
Biomet, Inc.1991—
*K971890Recovery Protrusio Cage
Summary page 3
…devices are predicated to the MRS-Titan: Osteonics restauration gap, K963946, Biomeds modular acetabular reconstructive system, K 911718, Biomeds recovery protrusio cup, K 971890, Osteonics modular acetabular cup, microstructured version, K 963946, Biomeds modular protrusio cup, K 990032 (here are several d…
Biomet, Inc.19971
*K990032Modular Protusio Cup
Summary page 3
…structive system, K 911718, Biomeds recovery protrusio cup, K 971890, Osteonics modular acetabular cup, microstructured version, K 963946, Biomeds modular protrusio cup, K 990032 (here are several different options with the use of a hook and straps). Indications for use: The MRS-Titan system is intended to…
Biomet, Inc.19991

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 3 companies; a new generation was cleared every 1.3 years on median.
  • 2 of the 9 ancestors have a recall of any class.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid arthritis, post traumatic arthritis.

Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other procedure.

Clinical management problem solve arthrodesis or alternative techniques are less likely to achieve satisfactory results.

Bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated deficiencies of the acetabulum.

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

More from Rotec Medizintechnik GmbH

2 FDA decisions under this applicant name. See the company

  • K992403MRP-TitanRotec Medizintechnik GmbH · 2000

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K992359 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992359: MRS-Titan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992359

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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