510(k) · Cleared
ClearedSurface Replacement Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KYB Lens, Guide, Intraocular
Cleared on Sep 18, 1981 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 18, 1981
- Review
- 92 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK811718 Surface Replacement Hip ProsthesisBiomet, Inc. · 1981
- Descendant · cites it directly · 7 of its ownK023188 Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK082673 Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008
- Descendant · 3 generations on · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · 2 generations on · 1 of its ownK071053 Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK043542 Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K023188Press-Fit Head Resurfacing DeviceBiomet Orthopedics, Inc. · 2002 · cites it directly7descendants
- K082673Conserve Pressfit Femoral ComponentWrightmedicaltechnologyinc · 2008 · 2 generations on2descendants
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · 3 generations on1descendant
- K071053Recap HA Press-Fit Femoral Resurfacing HeadBiomet, Inc. · 2007 · 2 generations on1descendant
- K043542Biopro Tara Femoral Resurfacing ComponentBiopro, Inc. · 2005 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811718 | Surface Replacement Hip Prosthesis | Biomet, Inc. | 1981 | — |
| +1 | K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | 2002 | — |
| +2 | K082673 | Conserve Pressfit Femoral Component | Wrightmedicaltechnologyinc | 2008 | — |
| +3 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +2 | K071053 | Recap HA Press-Fit Femoral Resurfacing Head | Biomet, Inc. | 2007 | — |
| +2 | K043542 | Biopro Tara Femoral Resurfacing Component | Biopro, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023188 | Press-Fit Head Resurfacing Device | 2002 | 7 |
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, K023188 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KYB
161in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KYB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYB
389in 2025
MAUDE reports naming product code KYB, 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 | 3 | 161 | 0 | 570 |
| 2008 | 2 | — | 1 | 258 |
| 2009 | 0 | — | 1 | 73 |
| 2010 | 0 | — | 0 | 81 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 125 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 1 | — | 0 | 160 |
| 2016 | 0 | — | 0 | 256 |
| 2017 | 0 | — | 0 | 335 |
| 2018 | 0 | — | 0 | 592 |
| 2019 | 0 | — | 0 | 703 |
| 2020 | 0 | — | 0 | 335 |
| 2021 | 0 | — | 0 | 349 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 0 | — | 1 | 393 |
| 2025 | 0 | — | 0 | 389 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K811718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811718: Surface Replacement Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811718
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026