510(k) · Cleared
Recalled · Class II · 2024Modification to: Acumatch L-Series Bipolar Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Dec 5, 2001 as substantially equivalent to K905370 (Exactech, Inc., 1991) after a 70-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905370 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905370 Exactech Bipolar Hip ProsthesisExactech, Inc. · 1991
- This deviceK013211 Modification to: Acumatch L-Series Bipolar EndoprosthesisExactech, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK173455 SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016 · cites it directly3descendants
- K162957U2 Femoral HeadUnited Orthopedic Corporation · 2017 · 2 generations on1descendant
- K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · 3 generations on0descendants
- K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905370 | Exactech Bipolar Hip Prosthesis | Exactech, Inc. | 1991 | — |
| 0 (this device) | K013211 | Modification to: Acumatch L-Series Bipolar Endoprosthesis | Exactech, Inc. | 2001 | — |
| +1 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| +2 | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
| +3 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
| +2 | K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 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? (6)
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 |
|---|---|---|---|
| * | K905370 | Exactech Bipolar Hip ProsthesisSummary page 1…atch L-Series Bipolar Endoprosthesis Legally Marketed Devices for Substantial Equivalence Comparison: Model Manufacturer 510(k) Number Exactech Bipolar Exactech, Inc. #K905370 Giliberty Zimmer Bi-articular Zimmer Centrax Howmedica Conversion Richards Self-Centering Depuy Device Description: INDICAT… | 1991 |
| * | — | Giliberty Named without a submission number | |
| * | — | Bi-articular Named without a submission number | |
| * | — | Centrax Named without a submission number | |
| * | — | Conversion Named without a submission number | |
| * | — | Self-Centering Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2024 | Class II | Z-2236-2024 | Other | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K152439 (United Orthopedic Corporation, 2016) has gone furthest, with 3 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?
All Exactech Hip Systems are indicated for use in skeletally mature individuals
undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid
arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for
treatment of proximal femoral fractures where prosthetic replacement is determined by
the surgeon as the preferred treatment. Components of Exactech Hip Systems are also
potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of
failed previous reconstructions where sufficient bone stock is present, and to restore
mobility resulting from previous fusion.
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/K013211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013211: Modification to: Acumatch L-Series Bipolar Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013211
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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