510(k) · Cleared
ClearedWorland Unicondylar Tibial Bearing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 13, 2001 as substantially equivalent to K980665 (Biomet, Inc., 1998) after a 5-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jun 13, 2001
- Review
- 5 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980665 (1998). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K030446Repicci Locked Keel Tibial BearingBiomet, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980665 | Repicci II Unicondylar Knee All Poly Tibial Components | Biomet, Inc. | 1998 | 1 |
| 0 (this device) | K011795 | Worland Unicondylar Tibial Bearing | Biomet, Inc. | 2001 | — |
| +1 | K030446 | Repicci Locked Keel Tibial Bearing | Biomet, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K980665 | Repicci II Unicondylar Knee All Poly Tibial ComponentsSummary page 1…esis, Knee, Femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.350) Substantially Equivalent Devices: Repicci II™ Unicondylar All Poly Tibial Bearing — K980665 Device Description: The Repicci II™ Unicondylar Knee System consists of a femoral and tibial component. The Worland tibial bear… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030446 | Repicci Locked Keel Tibial Bearing | 2003 | 0 |
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 HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.
The device is a single use implant intended for implantation with bone cement.
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/K011795 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011795: Worland Unicondylar Tibial Bearing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011795
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026