510(k) · Cleared
ClearedOrigin™ TT Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 11, 2025 as substantially equivalent to K192883 (Signature Orthopaedics Pty, Ltd., 2020) and 4 other predicates after a 165-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Mar 11, 2025
- Review
- 165 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K941847 (1994). 225 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- This deviceK243029 Origin™ TT StemSignature Orthopaedics Pty, Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 7 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 5 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 4 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- This deviceK243029 Origin™ TT StemSignature Orthopaedics Pty, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −7 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −5 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −4 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −1 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| 0 (this device) | K243029 | Origin™ TT Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 26 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K192883 | Spartan Hip StemSummary page 6…sis (KWY) Predicate Devices: Substantial equivalence to the following devices is claimed: • Signature Orthopaedics Spartan Hip Stem (K192883) • Signature Orthopaedics Encore Hip Stem (K211505) • Signature Orthopaedic… | 2020 |
| * | K211505 | Encore Hip StemSummary page 6…g devices is claimed: • Signature Orthopaedics Spartan Hip Stem (K192883) • Signature Orthopaedics Encore Hip Stem (K211505) • Signature Orthopaedics Origin Hip Stem (K121297) • DePuy Actis DuoFix Hi… | 2021 |
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 6…tan Hip Stem (K192883) • Signature Orthopaedics Encore Hip Stem (K211505) • Signature Orthopaedics Origin Hip Stem (K121297) • DePuy Actis DuoFix Hip Stem (K150862 and K160907)… | 2012 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 6…paedics Encore Hip Stem (K211505) • Signature Orthopaedics Origin Hip Stem (K121297) • DePuy Actis DuoFix Hip Stem (K150862 and K160907) K243029 p.2/3 Device… | 2015 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 6…re Hip Stem (K211505) • Signature Orthopaedics Origin Hip Stem (K121297) • DePuy Actis DuoFix Hip Stem (K150862 and K160907) K243029 p.2/3 Device Description:… | 2016 |
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 31 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 51 of the 224 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192883.
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. 2025, 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?
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis • Inflammatory joint disease including rheumatoid arthritis • Correction of functional deformity…
Read the full statement (303 words)
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics’ Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics’ SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics’ Logical/World Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243029: Origin™ TT Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243029
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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