510(k) · Cleared
ClearedFusion Taper System
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 Apr 16, 2021 as substantially equivalent to K073567 (Zimmer GmbH, 2008) and 2 other predicates after a 360-day review. Its family tree reaches back 13 generations to 1994. 1 of the 252 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 16, 2021
- Review
- 360 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K941847 (1994). 252 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet. 1 of the 252 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
- 1 generation backK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- This deviceK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 6 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 5 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 4 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
- 1 generation backK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- This deviceK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks3 generations back · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −6 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −5 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −4 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −2 | K102172 | Msa Hip System | Global Manufacturing Technology | 2011 | — |
| −1 | K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015 | — |
| 0 (this device) | K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 27 | 0 |
| 1995 | 17 | 0 |
| 1996 | 18 | 0 |
| 1997 | 11 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 23 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 1 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K073567 | Biolox Option Ceramic Femoral Head System, Model 8777 SeriesSummary page 4…imary Predicates Devices: * Zimmer's Biolox Option Femoral Head and Taper Sleeve (K073567) Secondary Predicates * Signature Orthopaedics' Evolve UniPo… | 2008 |
| * | K143184 | Evolve UniPolar HeadSummary page 4…Secondary Predicates * Signature Orthopaedics' Evolve UniPolar Head and Taper Sleeve (K143184) * Signature Orthopaedics' Signature Ceramic Femoral H… | 2015 |
| * | K190704 | Signature Ceramic Femoral HeadSummary page 4…Taper Sleeve (K143184) * Signature Orthopaedics' Signature Ceramic Femoral Head (K190704) Signature Orthopaedics Pty Ltd K201047 page 2/3… | 2019 |
| † | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 |
| † | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 |
| † | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS… | 2017 |
| † | K201278 | World Hip Stem, World Cup, World Liner | 2020 |
| † | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 63 of the 251 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K073567.
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. 2021, 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?
Signature Orthopaedics' Fusion Taper System is 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…
Read the full statement (108 words)
Signature Orthopaedics' Fusion Taper System is 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, hemi-arthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201047: Fusion Taper System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201047
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