510(k) · Cleared
ClearedBofor Revision Coup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 5, 2000 as substantially equivalent to K971854 (Howmedica Corp., 1997) and 1 other predicate after a 203-day review. Its family tree reaches back 2 generations to 1990. 65 later devices descend from it.
- Decided
- Jun 5, 2000
- Review
- 203 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903362 (1990). 6 ancestors in all. 65 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- 1 generation backK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
- This deviceK993874 Bofor Revision CoupPlus Orthopedics · 2000
- Descendant · cites it directly · 63 of its ownK011719 Plus Cancellous Bone ScrewsPlus Orthopedics · 2001
- Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 23 of its ownK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K011719Plus Cancellous Bone ScrewsPlus Orthopedics · 2001 · cites it directly63descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
- K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009 · 2 generations on23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| −1 | K971854 | Osteolock Acetabular Shell System | Howmedica Corp. | 1997 | — |
| 0 (this device) | K993874 | Bofor Revision Coup | Plus Orthopedics | 2000 | — |
| +1 | K011719 | Plus Cancellous Bone Screws | Plus Orthopedics | 2001 | — |
| +2 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +3 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +2 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K971854 | Osteolock Acetabular Shell SystemSummary page 1…s, hip, metal/ceramic/polymer, semi-constrained cemented or name: nonporous uncemented 21 CFR 888.3353 (87 LZO) Equivalence: Howmedica Osteolock Acetabular Shell System (K971854, SE date 07-30-97) and Howmedica Osteolock Acetabular Cup (K981201, SE date 05-29-98). Characteristics: The BOFOR Revision Cup… | 1997 |
| * | K981201 | Osteolock Acetabular CupSummary page 1…nporous uncemented 21 CFR 888.3353 (87 LZO) Equivalence: Howmedica Osteolock Acetabular Shell System (K971854, SE date 07-30-97) and Howmedica Osteolock Acetabular Cup (K981201, SE date 05-29-98). Characteristics: The BOFOR Revision Cup consists of a titanium shell (Ti 6Al 4V) and an UHMWPE insert with a… | 1998 |
What descends from it? (65)
See all 652 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K011719 (Plus Orthopedics, 2001) has gone furthest, with 63 descendants of its own.
- 2 other devices also cite its predicate K971854.
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 BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.
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/K993874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993874: Bofor Revision Coup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993874
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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