510(k) · Cleared
ClearedTGM Biolox delta Ceramic Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tgm Medical, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 9, 2015 as substantially equivalent to K131684 (Biomet, Inc., 2013) and 4 other predicates after a 187-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Sep 9, 2015
- Review
- 187 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K930712 (1993). 148 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations between
- 3 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 2 generations backK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
- 1 generation backK121636 Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head…Tgm Medical, Inc. · 2012
- This deviceK150576 TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 8 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 6 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 4 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- 3 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 2 generations backK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
- 1 generation backK121636 Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head…Tgm Medical, Inc. · 2012
- This deviceK150576 TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −8 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −6 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −4 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| −3 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| −2 | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr… | Tgm Medical | 2011 | — |
| −1 | K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert | Tgm Medical, Inc. | 2012 | — |
| 0 (this device) | K150576 | TGM Biolox delta Ceramic Heads | Tgm Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 21 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 11 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K131684 | Biolox (R) Delta Ceramic HeadsSummary page 4…esis Product Code: LZO (a)(3) Predicate Devices: Biomet Biolox® delta Heads (K131684) Depuy Biolox® delta Heads… | 2013 |
| * | K031803 | Depuy Ceramic Femoral HeadsSummary page 4…84) Depuy Biolox® delta Heads (K031803/K040644) TGM Helicon/Zenith Total Hip Systems… | 2003 |
| * | K040644 | Modification to Depuy Ceramic Femoral HeadSummary page 4…Depuy Biolox® delta Heads (K031803/K040644) TGM Helicon/Zenith Total Hip Systems… | 2004 |
| * | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Summary page 4…TGM Helicon/Zenith Total Hip Systems (K111472/K121636) (a)(4) Device Description: The Biolox® delta Ceramic Heads are modular femoral components used in hip arthrop… | 2011 |
| * | K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertSummary page 4…TGM Helicon/Zenith Total Hip Systems (K111472/K121636) (a)(4) Device Description: The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty.… | 2012 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 30 of the 147 ancestors have a recall of any class.
- 3 other devices also cite its predicate K131684.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E.…
Read the full statement (100 words)
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150576: TGM Biolox delta Ceramic Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150576
Report an extraction error
Are you the manufacturer?
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