(242 days)
Not Found
No
The document describes a mechanical hip replacement system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a hip replacement system intended to replace a hip joint for various medical conditions, which inherently involves treating or remediating a disease or injury.
No
Explanation: This device is a hip replacement system, indicated for surgical replacement of a hip joint. It is a prosthetic implant, not a tool for diagnosis.
No
The device description clearly outlines physical components made of titanium alloy and UHMWPE, which are hardware. The performance studies also focus on the mechanical properties and performance of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip replacement range intended to replace a hip joint. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components of a hip implant (stems, heads, cups) and the materials used. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is a surgical implant used to replace a damaged hip joint.
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 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
Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LPH
Device Description
The system is modular and consists of the Signature Orthopaedics Origin™ and NEO-T Hip Stem, Femoral Heads, and PX-Series and G-Series Acetabular Cups.
The Signature Orthopaedics Origin™ Hip Stem is manufactured from titanium alloy per ASTM F136 and below the resection line is coated with HA per ISO 13779-2. The stem is straight and tapered with a lateral chamfer to aid insertion. The stem has both vertical and horizontal grooves to resist axial and torsional loading.
The Signature Orthopaedics NEO-TTM Hip Stem is a porous coated femoral stem manufactured from titanium alloy per ASTM F136. The proximal stem below the resection line is porous coated with titanium powder per ASTM F1580. The stem is straight and tapered with a rectangular cross-section. The stem has a distal slot and lateral chamfer to ease insertion.
Both stems are available in standard and high offset neck geometries. Each stem's neck has a 12/14 morse taper for connection of a Cobalt Chrome or Ceramic (BIOLOX forte or BIOLOX Delta) femoral head.
The Logical™ PX-Series and G-Series Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liners. Both series of acetabular cup consist of a porous coated shell manufactured from titanium alloy per ASTM F136, and a modular liner manufactured from cross-linked UHMWPE per ASTM F648. The PX-Series and G-Series shells differ in their shell's porous coating. The PX-Series is coated with titanium beads while the G-series is coated with a combination of titanium beads and particles. Both series of cups are available with either no holes or three holes to allow the use of bone screws to supplement fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Origin™ Total Hip System is adequate for anticipated in-vivo use. Non-clinical testing included:
- . Range of motion analysis
- Articular surface wear simulation ●
- Modular component connection strength testing .
- Ceramic head burst testing .
- Femoral stem fatigue testing ●
- . Liner impingement testing
- Cup Liner Push, Lever Out and Torque Testing .
- Bone screw torsion testing .
- Various coating characterization, abrasion and adhesion strength testing
- Various crosslinked UHMWPE characterization, chemical and mechanical . testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K953111, K042992, K080980, K000306, K001534, K093646, K071784, K043537, K994366
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
510(K) SUMMARY
DEC 2 8 2012
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长121297
| Manufacturer: | Signature Orthopaedics Pty Ltd
126 Greville Street
Chatswood, NSW 2067
Australia |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Origin™ Total Hip System |
| Common Name: | Total Hip Prosthesis |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
126 Greville Street
Chatswood, NSW 2067
Australia
Phone: (011) 61 (2) 9419 4105
Fax: (011) 61 (2) 4271 8021 |
| Date Prepared: | April 20th, 2012 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented prosthesis
(MEH)
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented prosthesis (LPH) |
| Predicate Devices: | Substantial equivalence to the following devices is claimed:
• Landos Corail (K953111)
• DePuy's Corail AMT Hip Prosthesis (K042992)
• Exactech's Novation Element Hip Prosthesis (K080980)
• DePuy Pinnacle Acetabular System (K000306, K001534)
• DePuy Pinnacle with Gription Acetabular Cups (K093646, K071784)
• Biomet Taperloc 12/14 Taper Femoral Component (K043537)
• Howmedics Osteonics Corp. TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem (K994366)
• APEX Modular Hip System BIOLOX delta Femoral Head |
1 ·
:
1
Device Description:
The system is modular and consists of the Signature Orthopaedics Origin™ and NEO-T Hip Stem, Femoral Heads, and PX-Series and G-Series Acetabular Cups.
The Signature Orthopaedics Origin™ Hip Stem is manufactured from titanium alloy per ASTM F136 and below the resection line is coated with HA per ISO 13779-2. The stem is straight and tapered with a lateral chamfer to aid insertion. The stem has both vertical and horizontal grooves to resist axial and torsional loading.
The Signature Orthopaedics NEO-TTM Hip Stem is a porous coated femoral stem manufactured from titanium alloy per ASTM F136. The proximal stem below the resection line is porous coated with titanium powder per ASTM F1580. The stem is straight and tapered with a rectangular cross-section. The stem has a distal slot and lateral chamfer to ease insertion.
Both stems are available in standard and high offset neck geometries. Each stem's neck has a 12/14 morse taper for connection of a Cobalt Chrome or Ceramic (BIOLOX forte or BIOLOX Delta) femoral head.
The Logical™ PX-Series and G-Series Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liners. Both series of acetabular cup consist of a porous coated shell manufactured from titanium alloy per ASTM F136, and a modular liner manufactured from cross-linked UHMWPE per ASTM F648. The PX-Series and G-Series shells differ in their shell's porous coating. The PX-Series is coated with titanium beads while the G-series is coated with a combination of titanium beads and particles. Both series of cups are available with either no holes or three holes to allow the use of bone screws to supplement fixation.
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
Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
2
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Origin™ Total Hip System is adequate for anticipated in-vivo use. Non-clinical testing included:
- . Range of motion analysis
- Articular surface wear simulation ●
- Modular component connection strength testing .
- Ceramic head burst testing .
- Femoral stem fatigue testing ●
- . Liner impingement testing
- Cup Liner Push, Lever Out and Torque Testing .
- Bone screw torsion testing .
- Various coating characterization, abrasion and adhesion strength testing �
- Various crosslinked UHMWPE characterization, chemical and mechanical . testing
Substantial Equivalence:
The Origin™ Total Hip System has similar intended use, indications for use, materials and design to the predicate devices. Non-clinical testing results support the substantial equivalence claim. The Origin™ Total Hip System is expected to perform adequately during clinical use.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 28, 2012
Signature Orthopaedics, Pty Ltd % Dr. Declan Brazil Managing Director of Signature Orthopaedics 126 Greville Street Chatswood NSW 2067 Australia
Re: K121297
Trade/Device Name: Origin™ Total Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. Regulatory Class: Class II Product Code: MEH, LPH Dated: December 21, 2012
Received: December 26, 2012
Dear Dr. 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. 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
4
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 1
510(k) Number (if Known): K121297
Device Name: Origin™ Total Hip System
Indications For Use:
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
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
Components of the Signature Orthopaedics hip replacement range are intended for cementless fixation only.
Over-The-Counter Use: No Prescription Use: Yes AND/OR (Part 29 CFR 801 Subpart C) (Part 29 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi, PhD Division of Orthopedic Devices