510(k) · Cleared
Recalled · Class II · 2021Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 28, 2012 as substantially equivalent to K953111 (Landos, Inc., 1996) and 7 other predicates after a 242-day review. Its family tree reaches back 7 generations to 1993. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 28, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 10
Its longest line of descent runs back 7 generations to K930712 (1993). 77 ancestors in all, the oldest K830313 (1983). 20 later devices descend from it, 12 citing it directly.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 1 generation backK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- This deviceK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · cites it directly · 4 of its ownK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
- Descendant · cites it directly · 4 of its ownK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK241636 MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
- Descendant · cites it directly · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
- K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019 · cites it directly4descendants
- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016 · cites it directly4descendants
- K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024 · 2 generations on2descendants
- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | — |
| +1 | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +1 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019 | — |
| +1 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
| +2 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024 | — |
| +1 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 14 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953111 | CorailSummary page 1…ined porous-coated uncemented prosthesis (LPH) Predicate Devices: Substantial equivalence to the following devices is claimed: *Landos Corail (K9531 11) *DePuy's Corail AMT Hip Prosthesis (K(042992) *Exactech's Novation Element Hip P… | 1996 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 1…stantial equivalence to the following devices is claimed: *Landos Corail (K9531 11) *DePuy's Corail AMT Hip Prosthesis (K(042992) *Exactech's Novation Element Hip Prosthesis (K080980) *DePuy Pinnacle Acetabular… | 2005 |
| * | K080980 | Exactech Novation Element Press-Fit Femoral StemsSummary page 1…*Landos Corail (K9531 11) *DePuy's Corail AMT Hip Prosthesis (K(042992) *Exactech's Novation Element Hip Prosthesis (K080980) *DePuy Pinnacle Acetabular System (1(000306, KOO01534) *DePuy Pinnacle with Grip… | 2008 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 1…AMT Hip Prosthesis (K(042992) *Exactech's Novation Element Hip Prosthesis (K080980) *DePuy Pinnacle Acetabular System (1(000306, KOO01534) *DePuy Pinnacle with Gription Acetabular Cups (K093646, K07 1784)… | 2000 |
| Kept off the family tree | K0001534 | DePuy Pinnacle Acetabular System Number could not be read | |
| * | K093646 | Depuy Pinnacle with Gription Acetabular CupsSummary page 1…rosthesis (K080980) *DePuy Pinnacle Acetabular System (1(000306, KOO01534) *DePuy Pinnacle with Gription Acetabular Cups (K093646, K07 1784) *Biomet Taperloc 12/14 Taper Femoral Component… | 2009 |
| * | K071784 | Depuy Pinnacle with Gripton Acetabular CupsSummary page 1…*DePuy Pinnacle Acetabular System (1(000306, KOO01534) *DePuy Pinnacle with Gription Acetabular Cups (K093646, K07 1784) *Biomet Taperloc 12/14 Taper Femoral Component (K(043 537)… | 2007 |
| * | K043537 | Taperloc 12/14 Taper Femoral Components | 2005 |
| * | K994366 | TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemSummary page 1…(K(043 537) * Howmedics Osteonics Co rp. TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem (K(994366) * APEX Modular Hip System BIOLOX delta Femoral Head (KIC 145 1)… | 2000 |
| Kept off the family tree | K101451 | FDA’s K101451 is Apex Module Hip System Biolox Delta Femoral Head Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
What descends from it? (20)
See all 2012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 | 5 |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | 2019 | 4 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner… | 2016 | 4 |
| K241690 | Logical Liner; World Liner; World Knee Patella | 2024 | 2 |
| K190704 | Signature Ceramic Femoral Head | 2019 | 2 |
| K161155 | Origin Coxa Vara Hip Stem | 2016 | 1 |
| K143184 | Evolve UniPolar Head | 2015 | 1 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | 2026 | 0 |
| K243043 | Origin™ Cemented Hip Stem | 2025 | 0 |
| K243029 | Origin™ TT Stem | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2021 | Class II | Z-1694-2021 | Labeling mix-ups | Product mislabeled, with the incorrect product inside the package. |
| Feb 2, 2018 | Class II | Z-0920-2018 | Labeling mix-ups | This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 77 ancestors have a recall of any class.
- Of its descendants, K133370 (Signature Orthopaedics Pty Limited, 2014) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K953111.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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 defornity…
Read the full statement (108 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 defornity 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, hemniarthroplasty, surface.replacement, or total replacement
Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121297
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