510(k) · Cleared
Recalled · Class II · 2013United U2 Bipolar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Oct 8, 2010 as substantially equivalent to K050269 (United Orthopedic Corp., 2005) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981238 (1998). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK981238 Bipolar Femoral HeadWhiteside Biomechanics, Inc. · 1998
- 1 generation backK050269 U1 Hip System - BipolarUnited Orthopedic Corp. · 2005
- This deviceK101670 United U2 Bipolar ImplantUnited Orthopedic Corp. · 2010
- 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
- Descendant · cites it directly · 0 of its ownK130149 U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013
Most influential descendants
Showing 5 of 5 · 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
- K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981238 | Bipolar Femoral Head | Whiteside Biomechanics, Inc. | 1998 | — |
| −1 | K050269 | U1 Hip System - Bipolar | United Orthopedic Corp. | 2005 | — |
| 0 (this device) | K101670 | United U2 Bipolar Implant | United Orthopedic Corp. | 2010 | — |
| +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 | — |
| +1 | K130149 | U2 Hip System, Expanded Indications for Use | United Orthopedic Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K050269 | U1 Hip System - BipolarSummary page 1…oint femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis per 21CFR 888.3390. This falls under the Orthopedics panel. 1. “UNITED” Ul Hip System — Bipolar (K050269) 2. “Wright” GLADIATOR Bipolar System (K062693) “UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface… | 2005 |
| * | K062693 | Gladiator Bipolar SystemSummary page 1…r Uncemented Prosthesis per 21CFR 888.3390. This falls under the Orthopedics panel. 1. “UNITED” Ul Hip System — Bipolar (K050269) 2. “Wright” GLADIATOR Bipolar System (K062693) “UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface between femoral head and U2 Bipolar Implant, is… | 2006 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-1383-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K152439 (United Orthopedic Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K050269.
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. 2010, this device’s year, is highlighted.
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?
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement in skeletally mature patients with the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as theumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmaunageable using other techniques.
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/K101670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101670: United U2 Bipolar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101670
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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