510(k) · Cleared
ClearedTri-Polar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Sep 10, 1999 after an 88-day review. The FDA summary names its predicate without a number. 105 later devices descend from it.
- Decided
- Sep 10, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 0
105 later devices descend from it, 5 citing it directly.
- This deviceK991990 Tri-Polar SystemBiomet, Inc. · 1999
- Descendant · cites it directly · 78 of its ownK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- Descendant · 2 generations on · 59 of its ownK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · Recalled
- Descendant · cites it directly · 27 of its ownK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011 · Recalled
- Descendant · cites it directly · 25 of its ownK051569 Ringloc BI-Polar Acetabular ComponentBiomet, Inc. · 2005 · Recalled
- Descendant · cites it directly · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K070278Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007 · cites it directly78descendants
- K083116Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · 2 generations on59descendants
- K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Serf · 2011 · cites it directly27descendants
- K051569Ringloc BI-Polar Acetabular ComponentBiomet, Inc. · 2005 · cites it directly25descendants
- K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| +1 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| +2 | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | 2 |
| +1 | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | 5 |
| +1 | K051569 | Ringloc BI-Polar Acetabular Component | Biomet, Inc. | 2005 | 4 |
| +1 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | THARIES Surface Replacement System Named without a submission number | |
| * | — | Indiana Conservative Hip Named without a submission number | |
| * | — | Mallory Head Total Hip Named without a submission number |
What descends from it? (105)
See all 1055 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?
- Of its descendants, K070278 (Plus Orthopedics AG, 2007) has gone furthest, with 78 descendants of its own.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular NECrosis.
b.) Rheumatoid arthritis
c.) Correction of functional deformity
d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
e.) Revision of previously failed total hip arthroplasty due to recurrent dislocation.
The Tri-Polar System is intended for cemented or press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
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/K991990 · printed Nov 3, 2026
Cite this page
510(k) Report. “K991990: Tri-Polar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K991990
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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