510(k) Report

510(k) · Cleared

Cleared

Osteonics Gap-II Restoration Acetabular Shells

K980774510(k) TraditionalCleared Apr 29, 199858-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

Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 29, 1998 after a 58-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided
Apr 29, 1998
Review
58 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2003: 1 descendant cleared2022: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980774 Osteonics Gap-II Restoration Acetabular ShellsOsteonics Corp. · 1998
  2. Descendant · cites it directly · 5 of its ownK222632 UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
  3. Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  4. Descendant · cites it directly · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  5. Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  6. Descendant · 2 generations on · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003: 12017: 12018: 12022: 12023: 22024: 12025: 22026: 2
2003high 2 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · cites it directly3descendants
  • K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980774Osteonics Gap-II Restoration Acetabular ShellsOsteonics Corp.1998—
+1K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+1K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201710
201810
202210
202320
202410
202520
202620
FIG. 1 — Lineage of K980774, 1998–2026Source: 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
*—Osteonics® Restoration Acetabular Cup Series
Named without a submission number
—
*—Osteonics® Omnifit® Cup Inserts
Named without a submission number
—
*—Osteonics® Concentric Polyethylene Acetabular Cup
Named without a submission number
—
*—Osteonics® Flanged Polyethylene Acetabular Cup
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225
K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173
K032348Converge Reti-Lock Multi-Hole Reinforcement CupCenterpulse Orthopedics, Inc.20030

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?

  • Of its descendants, K222632 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2022) has gone furthest, with 5 descendants of its own.

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?

The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral- head replacement, cup arthreplasty- or-other -- procedure. Clinical…

Read the full statement (102 words)

The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

Revision of previous unsuccessful femoral- head replacement, cup arthreplasty- or-other --

procedure.

Clinical management problems where arthrodesxs or alternative reconstructive techniques

are less likely to achieve satisfactory results:- A

Where bone stock is of poor quality or is madequate for other reconstructive techniques as

indicated by deficiencies of the acetabulum.

Class III cavitary and segmental defects.

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

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

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/K980774 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980774: Osteonics Gap-II Restoration Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980774

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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