510(k) · Cleared
ClearedSurgTech Bipolar Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgtech, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jun 14, 2018 as substantially equivalent to K931655 (Johnson & Johnson Orthopaedics, Inc., 1994) and 3 other predicates after a 219-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Jun 14, 2018
- Review
- 219 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K941847 (1994). 67 ancestors in all, the oldest K800207 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 2 generations backK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- 1 generation backK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- This deviceK173455 SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −6 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −5 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −2 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| −1 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| 0 (this device) | K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K931655 | P.F.C. Bipolar Hip SystemSummary page 4…KWY (a)(3) Predicate Devices: Primary: J&J ORTHOPAEDICS-PFC BIPOLAR (K931655) Additional: United Orthopedic-U2 BIPOLAR (K152439); Additional:… | 1994 |
| * | K152439 | U2 Bipolar Implant and 22mm Femoral HeadSummary page 4…J&J ORTHOPAEDICS-PFC BIPOLAR (K931655) Additional: United Orthopedic-U2 BIPOLAR (K152439); Additional: Stryker-UHR Bipolar (K800207); Additional:… | 2016 |
| * | K800207 | Uhr UNIVERSAL6HIP ReplacementSummary page 4…United Orthopedic-U2 BIPOLAR (K152439); Additional: Stryker-UHR Bipolar (K800207); Additional: Howmedica – CENTRAX (K855231) Reference:… | 1980 |
| * | K855231 | Howmedica Bipolar ProsthesisSummary page 4…ional: Stryker-UHR Bipolar (K800207); Additional: Howmedica – CENTRAX (K855231) Reference: SurgTech-MALUC (K162125); *No predicate has been sub… | 1986 |
| † | K162125 | MALUC™ Total Hip Arthroplasty System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 21 of the 66 ancestors have a recall of any class.
- 3 other devices also cite its predicate K931655.
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. 2018, 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?
The SurgTech Bipolar Head system is intended for use for cases of:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• Inflammatory degenerative joint disease such as rheumatoid 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 unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173455: SurgTech Bipolar Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173455
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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