(415 days)
Not Found
No
The summary describes a hip replacement system and its components, focusing on material compatibility and mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a hip replacement system, which clearly states its intention to replace a hip joint for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device described is a hip replacement system, which is a therapeutic device intended to replace a damaged hip joint. It is not used for diagnosing medical conditions.
No
The device description and performance studies clearly indicate that the device is a physical hip replacement system, not a software-only device. The testing performed relates to the mechanical properties and performance of physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes components of a hip replacement range, which are surgically implanted devices used to replace a damaged hip joint.
- Intended Use: The intended use clearly states the devices are for replacing a hip joint due to various conditions affecting the joint itself. This is a surgical intervention, not an in vitro test.
The information provided focuses on the mechanical and biological performance of the implant components, which is typical for a surgical device, not an IVD.
N/A
Intended Use / 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 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, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems 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 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
Product codes (comma separated list FDA assigned to the subject device)
LPH, MEH, KWZ, OQG, LZO, KWY
Device Description
The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head/neck, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, medical professionals in a care setting where hip replacement surgery is performed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testings were evaluated as part of the engineering evaluations:
- . Ceramic Head Testings per ISO 7206-10
- . Ceramic Head Fatigue Burst Testing and Rotational Stability per Ceramtec Protocol
- Range of Motion per ISO 21535
- . Rim Impingement per ASTM-F2582-14
- Stem Body Fatigue per ISO 7206-4 •
- . Stem Neck Fatigue per ISO 7206-6
- Articulating Surface Wear per ISO 14242-1
- Head Constrained Liner Assembly per Custom Protocol .
- . Head - Constrained Liner Disassembly per ISO 7206-10
- . Head Pull Out per ISO 7206-10
- . Fretting Corrosion Testing per ASTM-F1875
- . Head Pull Out from BiPolar
- . Femoral Head - Constrained Liner Lever-Out Disassembly
The engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K161155, K163081, K121297, K133370, K023794, K072154, K130365, K140130, K974093, K974095, K973119, K190057, K082844, K953510
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
August 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Signature Orthopaedics Pty Ltd. Declan Brazil Mananging Director 7 Sirius Road Lane Cove. 2066 Au
Re: K191708
Trade/Device Name: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral 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, MEH, KWZ, OQG, LZO, KWY Dated: July 9, 2020 Received: July 20, 2020
Dear Declan Brazil:
We have reviewed your Section 510(k) premarket 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191708
Device Name
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
Indications for Use (Describe)
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 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, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems 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 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name: | Origin Stem |
| | Evolve Stem |
| | Aria Hip Stem |
| | Remedy Stem |
| | CoCr Femoral Head |
| Common Name: | Hip Replacement Prostheses |
| Contact: | Dr. Declan Brazil |
| | Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road |
| | Lane Cove, NSW 2066 |
| | Australia
Phone: +61 (2) 9428 5181 |
| | Fax: +61 (2) 8456 6065 |
| Date Prepared: | August 14th, 2020 |
| Classification: | LPH - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis per 21 CFR 888.3358 |
| | MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis per 21 CFR 888.3353 |
| | KWZ - Hip joint metal/polymer constrained cemented or uncemented
prosthesis per 21 CFR 888.3310 |
| | OQG - Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis per 21 CFR 888.3358 |
| | LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis per 21 CFR 888.3353 |
| | KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis per 21 CFR 888.3390 |
| Predicate
Devices: | Substantial equivalence to the following devices is claimed: |
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Primary Predicate:
- Signature Orthopaedics Origin Coxa Vara hip stem (K161155) .
Secondary Predicate:
- . 40 - 42mm BiPolar Head and 22mm Femoral Head (K163081)
- Signature Orthopaedics Origin hip stem (K121297) •
- Signature Orthopaedics Aria hip stem (K121297) .
- . Signature Orthopaedics CoCr femoral head (K121297)
- . Signature Orthopaedics Remedy hip stem (K133370)
- Signature Orthopaedics Evolve hip stem (K133370) .
- FMP Constrained Liners (K023794)
- X-alt HXL Poly Liners (K072154) .
- . X-alt Highly Cross Linked Acetabular Liner with Vitamin E (K130365 & K140130)
- Foundation Porous Coated Hemispherical Acetabular Cup (K974093)
- FMP Hemispherical Shells (K974093) ●
- . Foundation Porous Coated Flared Rim Acetabular Cup (K974095)
- . Foundation Porous Acetabular System (K973119)
- . EMPOWR Acetabular System, Cup (K190057)
- EMPOWR Acetabular System, Liner (K190057) .
- . Biolox Ceramic Femoral Head (K082844)
- Encore Medical BiPolar Head (K953510)
Device Description:
The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.
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 treaent, 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
5
Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems 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
Performance Testing:
The following non-clinical testings were evaluated as part of the engineering evaluations:
- . Ceramic Head Testings per ISO 7206-10
- . Ceramic Head Fatigue Burst Testing and Rotational Stability per Ceramtec Protocol
- Range of Motion per ISO 21535
- . Rim Impingement per ASTM-F2582-14
- Stem Body Fatigue per ISO 7206-4 •
- . Stem Neck Fatigue per ISO 7206-6
- Articulating Surface Wear per ISO 14242-1
- Head Constrained Liner Assembly per Custom Protocol .
- . Head - Constrained Liner Disassembly per ISO 7206-10
- . Head Pull Out per ISO 7206-10
- . Fretting Corrosion Testing per ASTM-F1875
- . Head Pull Out from BiPolar
- . Femoral Head - Constrained Liner Lever-Out Disassembly
The engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility.
Substantial Equivalence:
There are no changes to the indications for use or technology including features and material except for the principles of operation. This 510k is for a change in principle of operation where the compatibility of the subject devices are extended. The change in principle of operation of the subject devices was assessed and found to remain substantially equivalent to the predicate devices.
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Comparison of technological characteristics
The subjected devices were not subjected to any technological changes, therefore, remain exactly the same as their predicate devices which were originally cleared.