REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
Applicant
Signature Orthopaedics Pty Limited
Product Code
LPH · Orthopedic
Decision Date
Jul 22, 2014
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3358
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
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
Device Story
Hip prosthesis system comprising Remedy, Pegasus, and Evolve femoral stems and BiPolar Head; used in total or hemi-hip arthroplasty. Remedy and Pegasus stems are cementless; Evolve stem is cemented. Stems connect to femoral heads via 12/14 taper. BiPolar Head consists of stainless steel shell and UHMWPE insert, articulating against 28mm cobalt-chrome femoral head. Used in clinical/surgical settings by orthopedic surgeons. Devices replace damaged hip joints to restore function and alleviate pain. Stems provide structural support to femur; BiPolar Head allows articulation within natural acetabulum. Clinical benefit includes improved mobility and pain reduction for patients with degenerative or traumatic hip conditions.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including range of motion analysis, component connection strength, fretting corrosion testing, ceramic head burst testing, femoral stem fatigue testing, coating characterization (abrasion/adhesion), and BiPolar head disclamping resistance testing.
Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), inflammatory joint disease (rheumatoid arthritis), functional deformity (congenital hip dysplasia), traumatic injury (traumatic arthritis, femoral head/neck fracture), or failed previous hip surgery. BiPolar Head indicated for hemi-hip arthroplasty in patients with femoral head/neck/proximal femur fractures or pathologies (e.g., acute fracture, fracture dislocation, avascular necrosis, non-union, high subcapital fractures in elderly, degenerative arthritis).
Regulatory Classification
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Predicate Devices
Signature Orthopaedics Origin Total Hip System (K121297)
Signature Orthopaedics Logical G-Series Acetabular Cup (K121297)
Submission Summary (Full Text)
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Signature Orthopaedics Pty Ltd
# JUL 2 2 2014
| 2 | 510(K) SUMMARY | |
|-------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| JUL 22 2014 | | |
| | Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia |
| | Device Trade Name: | Remedy™™, Pegasus™ and Evolve™ Hip Stems and BiPolar<br>Head |
| | Common Name: | Hip Prosthesis |
| | Contact: | Dr. Declan Brazil<br>Managing Director |
| | Prepared By: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br>Phone: +61 (2) 9428 5181<br>Fax: +61 (2) 8456 6065 |
| | Date Prepared: | October 30th, 2013 |
| | Classification: | Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal<br>semi-constrained porous-coated uncemented prosthesis (LPH)<br>Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer<br>semi-constrained cemented or nonporous uncemented prosthesis<br>(LZO)<br>Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-<br>constrained cemented prosthesis (JDI)<br>Class II per 21 CFR 888.3390: Hip joint femoral (hemi-hip)<br>metal/polymer cemented or uncemented prosthesis (KWY) |
| | Predicate Devices: | Substantial equivalence to the following devices is claimed:<br>• Signature Orthopaedics Origin Total Hip System<br>(K121297)<br>• DePuy Titanium Tri-Lock Hip Stem (K010367)<br>• Smith & Nephew SL PLUS Standard and Lateral Femoral<br>Hip Stem (K072852)<br>• Howmedica Exeter Hip Stem (K110290) |
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### Signature Orthopaedics Pty Ltd
- · Howmedica Exeter Distal Centralizer (K974054)
- · Smith & Nephew Buck Cement Restrictor (K791125)
- · DePuy Self-Centering Hip (K812672)
- Medacta Bipolar Heads (K091967)
### Device Description:
The Remedy™ and Pegasus™ hip stems are intended for cementless use in total hip arthroplasty. The Evolve™ hip stem is intended for cemented total hip arthoplasty. The Remedy™, Pegasus™ and Evolve™ hip stems connect to a femoral head (cobalt-chrome allov or ceramic) via 12/14 taper connection.
The Remedy™ Hip Stem has a tapered wedge geometry. The stem is manufactured from titanium alloy per ASTM F136. The proximal stem is porous coated with titanium beads and particles per ASTM F67 and the distal stem is matte finished.
The Pegasus™ is a double tapered, straight stem with rectangular cross-section. The stem has a lateral wing for engaging the greater trochanter. The stem is manufactured from titanium alloy per ASTM F136. The stem is grit blasted below the resection line.
The Evolve™ Hip Stem is a highly polished, tapered wedge stem with a rounded crosssection. The Evolve™ Hip Stem is manufactured from high nitrogen stainless steel per ISO 5832-9. The Evolve™ Hip Stem is available in two variants, the Masters series and the Helios Series. Both variants share similar general geometry but are sized differently to provide a more complete range. The Evolve™ Hip Stem includes two accessories, the Evolve™ Distal Centralizer and Evolve™ Cement Plug. The Evolve™ Distal Centralizer is a PMMA cap that sits on the end of the Evolve™ Hip Stem and centralizes it within the femoral canal. The Evolve™ Cement Plug is manufactured from polyethylene per ASTM F648 and is pressed into the femoral canal prior to inserting the Evolve™ Hip Stem to allow cement pressurization.
The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The 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 hip hemiarthroplasty.
#### Indications for Use:
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
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## Signature Orthopaedics Pty Ltd
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 headineck 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
### Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head are adequate for anticipated in-vivo use. Non-clinical testing included:
- . Range of motion analysis
- . Component connection strength and fretting corrosion testing
- . Ceramic head burst testing
- . Femoral stem fatigue testing
- Various coating characterization, abrasion and adhesion strength testing ●
- . BiPolar head disclamping resistance testing
#### Substantial Equivalence:
The Remedy™ Hip Stem's design is similar to the DePuy Titanium Tri-Lock Hip Stem (K010367) predicate device and the porous coating is identical to the Signature Orthopaedics Logical G-Series Acetabular Cup (K121297). The Pegasus™ 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 Evolve™ Hip Stem's design is similar to the Howmedica Exeter Hip Stem (K110290). 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 (K812672) predicate device. The Remedy™, Pegasus™ and Evolve™ Hip Stems are identical to the Signature Orthopaedics Total Hip System (K121297) in terms of intended use, indications for use, modular connection design, material, sterilization and packaging. The BiPolar head also shares identical modular connection design, material, sterilization and packaging as the Signature Orthopaedics Total Hip System (K121297), but it is intended for use as part of a hip hemi-arthroplasty. Non-clinical testing results support the substantial equivalence claim. The RemedyTM, Pegasus™ and Evolve™ Hip Stems and BiPolar Head are expected to perform adequately during clinical use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2014
Signature Orthopedics Pty Ltd Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove. NSW 2066 Australia
Re: K133370
Trade/Device Name: Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI, KWY Dated: June 19, 2014 Received: June 26, 2014
Dear Dr. Brazil:
We have reviewed your Section 510(k) promarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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# Page 2 - Dr. Declan Brazil
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### 1 INDICATIONS FOR USE STATEMENT
510(k) Number (if Known): - K1333370
Device Name: Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head
Indications For Use:
Components of the Signature Orthopsedies hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgen has selected prosibetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis .
- . Inflammatory joint disease including theumatoid 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 Orthopactics' Evolve temoral stems are intended for cemented fixation only.
Signature Orthopactics' BiPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPotar Head is indicated for bone fractures or pathologies involving only the femoral headment 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 .
Over-The-Counter Use: No Prescription Use: Yes AND/OR (Part 29 CFR 801 Subpart D) (Part 29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Elizabeth南%rank -S
Division of Orthopedic Devices
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
