510(k) · Cleared
ClearedTreasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tgm Medical, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Nov 5, 2012 as substantially equivalent to K922560 (U.S. Medical Products, Inc., 1992) and 2 other predicates after a 168-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Nov 5, 2012
- Review
- 168 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K930712 (1993). 80 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 7 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 6 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 5 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 3 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- 2 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 1 generation backK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
- This deviceK121509 Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −7 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −6 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −5 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −3 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| −2 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| −1 | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr… | Tgm Medical | 2011 | — |
| 0 (this device) | K121509 | Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert | Tgm Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 13 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K922560 | Consensus (TM) Bipolar SystemSummary page 2…perSet femoral stem (K1 02399) to TGM Medical, Inc. which was cleared as the H-elicon Hip System (Ki 11472). COT has also licensed their previously cleared Bipolar Head (K922560) to TOM for use with Helicon. The components of the new device employ identical materials, design features, packaging and sterili… | 1992 |
| * | K102399 | Consensus Taperset Hip SystemSummary page 2…2 Technological C/aaracteristics/SubstantialEquivalence: Consensus Orthopedics, Inc. (COI) licensed the previously cleared TaperSet femoral stem (K1 02399) to TGM Medical, Inc. which was cleared as the H-elicon Hip System (Ki 11472). COT has also licensed their previously cleared Bip… | 2010 |
| * | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Summary page 2…Bipolar System U.S. Medical Products, Inc. 09/11/1992 K102399 Consensus TaperSet Hip System Consensus Orthopedics, Inc. 12/02/2010 Ki111472 Helicon Hip System TGM Medical, Inc. 9/06/2011I Non-Clinical Performance Data: No new perfor… | 2011 |
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 19 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 80 ancestors have a recall of any class.
- 2 other devices also cite its predicate K922560.
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. 2012, 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 Treasure Bipolar Head is intended for use as follows:
A. Fractures of the proximal femur;
B. Nonunions of proximal femoral neck fractures;
C. Aseptic necrosis of the femoral head;
D. Osico-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum;
E. Salvage of failed total hip arthroplasty.
The Treasure Bipolar Head is intended for cementless use.
The Treasure Bipolar Head is intended for use with the Helicon Hip System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121509: Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121509
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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