510(k) · Cleared
ClearedOsteolock Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 29, 1998 as substantially equivalent to K903362 (Howmedica Corp., 1990) after a 57-day review. Its family tree reaches back 1 generation to 1990. 66 later devices descend from it.
- Decided
- May 29, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903362 (1990). 66 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- This deviceK981201 Osteolock Acetabular CupHowmedica Corp. · 1998
- Descendant · cites it directly · 65 of its ownK993874 Bofor Revision CoupPlus Orthopedics · 2000
- Descendant · 2 generations on · 63 of its ownK011719 Plus Cancellous Bone ScrewsPlus Orthopedics · 2001
- Descendant · 3 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 4 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 23 of its ownK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K993874Bofor Revision CoupPlus Orthopedics · 2000 · cites it directly65descendants
- K011719Plus Cancellous Bone ScrewsPlus Orthopedics · 2001 · 2 generations on63descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 3 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 4 generations on32descendants
- K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| 0 (this device) | K981201 | Osteolock Acetabular Cup | Howmedica Corp. | 1998 | — |
| +1 | K993874 | Bofor Revision Coup | Plus Orthopedics | 2000 | — |
| +2 | K011719 | Plus Cancellous Bone Screws | Plus Orthopedics | 2001 | — |
| +3 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +4 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +3 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 0 |
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 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903362 | Osteolock (TM) Acetabular CupSummary page 1…valence in intended use, materials, design, operational principles, and relative indications and contraindications to the currently marketed Osteolock™ ™ Acetabular Cup (K903362). L SERVICE, % WAEALTY & ot &, R DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service _ Food and Drug… | 1990 |
What descends from it? (66)
See all 661 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993874 | Bofor Revision Coup | 2000 | 65 |
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?
How does its category compare?
All LZO devicesLZO 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Osteolock™ Acetabular Cup is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981201 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981201: Osteolock Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981201
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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