510(k) · Cleared
ClearedRemedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty Limited · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 22, 2014 as substantially equivalent to K121297 (Signature Orthopaedics Pty, Ltd., 2012) and 9 other predicates after a 260-day review. Its family tree reaches back 8 generations to 1993. 5 later devices descend from it.
- Decided
- Jul 22, 2014
- Review
- 260 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 8 generations to K930712 (1993). 104 ancestors in all, the oldest K791125 (1979). 5 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 7 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 6 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 5 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 3 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 2 generations backK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 1 generation backK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- This deviceK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014
- Descendant · cites it directly · 1 of its ownK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK243043 Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral…Signature Orthopaedics Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK192024 Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015 · cites it directly1descendant
- K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd. · 2025 · cites it directly0descendants
- K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021 · 2 generations on0descendants
- K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd. · 2020 · cites it directly0descendants
- K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −7 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −6 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −5 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −2 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
| 0 (this device) | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip… | Signature Orthopaedics Pty Limited | 2014 | — |
| +1 | K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015 | — |
| +1 | K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +2 | K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021 | — |
| +1 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | 2020 | — |
| +1 | K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 17 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 8 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 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? (11)
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 |
|---|---|---|---|
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 2…olished to articulate against the patient's natural acetabulum. Thre insert articulates against a Signature Orthopaedics 28mm cobalt-chrome femoral head (K121297). The 28mm femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hrip hemi-… | 2012 |
| * | K010367 | Modification to Titanium Tri-Lock Hips StemSummary page 1…*Signature Orthopaedics Origin Total Hip System (K(12 1297) *DePuy Titanium Tni-Lock Hip Stem (K010367) *Smith & Nephew SL PLUS Standard and Lateral Femoral Hi… | 2001 |
| * | K072852 | SL-Plus Standard and Lateral Hip StemsSummary page 3…the Signature Orthopaedics Logical 0-Series Acetabular Cup (K121297). The Pegasust m Hip Stem's design is similar to the Smith & Nephew SL PLUS Hip Stem (K072852) and the Zimmer Zweymuller SL Hip Stem (K962101) predicate devices. The Evolvem Hip Stem's design is similar to t… | 2008 |
| Kept off the family tree | K010290 | Howmedica Exeter Hip Stem Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K040803 | MS-30 Femoral Stem Standard and LateralSummary page 1…Hip Stem (K(072852) *Howmedica Exeter Hip Stem (K( 10290) *Zimmer MS-30 Femorall Stem (1(040803) K133370 Page 2 of 3 Signature Orthopaedics Pty Ltd… | 2004 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 2…K133370 Page 2 of 3 Signature Orthopaedics Pty Ltd *Howmedica Exeter Distal Centralizer (K974054) *Smith & Nephew Buck Cement Restrictor (K791 125) *DePuy… | 1997 |
| * | K791125 | Plug-Lok Cement RestirctorSummary page 2…Pty Ltd *Howmedica Exeter Distal Centralizer (K974054) *Smith & Nephew Buck Cement Restrictor (K791 125) *DePuy Self-Centering Hip (K8 12672) *Medacta Bipolar He… | 1979 |
| * | K812672 | Self-Centering HipSummary page 2…entralizer (K974054) *Smith & Nephew Buck Cement Restrictor (K791 125) *DePuy Self-Centering Hip (K8 12672) *Medacta Bipolar Heads (K091967) Device Description: The RemedyTM and Pegas… | 1981 |
| * | K091967 | Medacta Bipolar HeadSummary page 2…ew Buck Cement Restrictor (K791 125) *DePuy Self-Centering Hip (K8 12672) *Medacta Bipolar Heads (K091967) Device Description: The RemedyTM and PegasusTm hip stems are intended for cementless use in total hip a… | 2010 |
| * | K962101 | Zweymueller SL Femoral Hip StemSummary page 3…abular Cup (K121297). The Pegasust m Hip Stem's design is similar to the Smith & Nephew SL PLUS Hip Stem (K072852) and the Zimmer Zweymuller SL Hip Stem (K962101) predicate devices. The Evolvem Hip Stem's design is similar to the Howniedica Exeter Hip Stem (KI 10290). The Evolve" Hi… | 1996 |
| * | K980843 | Exeter Intramedullary Bone PlugSummary page 3…the Howniedica Exeter Hip Stem (KI 10290). The Evolve" Hip Stem's distal centralizer and cement plug are similar to those of the Exeter stem, K974054 and K980843 respectively. The BiPolar Head's design is similar to the DePuy Self-Centering Hip (K8 12672) predicate device. The Remed… | 1998 |
What descends from it? (5)
4 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 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 20 of the 104 ancestors have a recall of any class.
- Of its descendants, K143184 (Signature Orthopaedics Pty, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K121297.
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. 2014, 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 deformity…
Read the full statement (213 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, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only. Signature Orthopaedics' Bipolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPolar Head is 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/K133370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133370
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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