510(k) · Cleared
ClearedSignature Ceramic Femoral Head
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 Aug 28, 2019 as substantially equivalent to K121297 (Signature Orthopaedics Pty, Ltd., 2012) and 1 other predicate after a 163-day review. Its family tree reaches back 10 generations to 1985. 2 later devices descend from it.
- Decided
- Aug 28, 2019
- Review
- 163 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K850055 (1985). 158 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 6 generations between
- 3 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 2 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 1 generation backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- This deviceK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 9 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 8 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 7 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 6 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 5 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 4 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 3 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 2 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 1 generation backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- This deviceK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −9 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −8 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −7 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −6 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −5 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −4 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| −3 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
| −2 | K131279 | Iconacy I-Hip System | Iconacy Orthopedic Implants, LLC | 2013 | — |
| −1 | K151307 | ICONACY (TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016 | — |
| 0 (this device) | K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +1 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
| +1 | K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 22 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 5…te Devices: Primary Predicate • Signature Orthopaedics Signature Ceramic Femoral Head (K121297) Additional Predicate • ICONACY Orthopedic Implants ICONAC… | 2012 |
| * | K151307 | ICONACY (TM) I-Hip (TM)Summary page 5…Additional Predicate • ICONACY Orthopedic Implants ICONACY I-Hip Ceramic Head (K151307) Device Description: The modular Signature Ceramic Femoral Head is composed of alumina matrix composi… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 34 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 34 of the 158 ancestors have a recall of any class.
- Of its descendants, K240452 (Microport Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K121297.
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. 2019, 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 (267 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, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. 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/K190704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190704: Signature Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190704
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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