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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the "Origin™ Total Hip System," a medical device, which typically focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe a study that uses human subjects, expert review, AI, or statistical measures like sensitivity, specificity, or AUC, which are common for AI/ML device evaluations. Therefore, many of the requested categories (2-9) are not applicable to this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds that the device had to meet, nor does it provide detailed quantitative "reported device performance" against such criteria in a granular manner. Instead, it lists various non-clinical tests performed to verify the device's performance is "adequate for anticipated in-vivo use" and to support substantial equivalence.

Performance Test	Reported Device Performance (Summary)
Range of motion analysis	Performed; adequate for anticipated in-vivo use
Articular surface wear simulation	Performed; adequate for anticipated in-vivo use
Modular component connection strength testing	Performed; adequate for anticipated in-vivo use
Ceramic head burst testing	Performed; adequate for anticipated in-vivo use
Femoral stem fatigue testing	Performed; adequate for anticipated in-vivo use
Liner impingement testing	Performed; adequate for anticipated in-vivo use
Cup Liner Push, Lever Out and Torque Testing	Performed; adequate for anticipated in-vivo use
Bone screw torsion testing	Performed; adequate for anticipated in-vivo use
Various coating characterization, abrasion, and adhesion strength testing	Performed; adequate for anticipated in-vivo use
Various crosslinked UHMWPE characterization, chemical, and mechanical testing	Performed; adequate for anticipated in-vivo use

2. Sample size used for the test set and the data provenance

Not Applicable (N/A): This document describes non-clinical, in-vitro/mechanical testing, not a study involving human subjects or data that would have a "test set" in the context of an AI/ML device. The "sample size" would refer to the number of physical components tested (e.g., number of femoral stems for fatigue testing, number of ceramic heads for burst testing), but these specific numbers are not provided in this summary. The data provenance is laboratory testing conducted by the manufacturer, Signature Orthopaedics Pty Ltd, in Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A): This is a non-clinical device that does not involve expert adjudication or ground truth establishment in the way an AI/ML diagnostic device would. Performance is measured using established engineering standards and methodologies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable (N/A): See #3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable (N/A): This document is about a mechanical implant, not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A): This document is about a mechanical implant, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable (N/A): As this is non-clinical testing for a mechanical implant, the "ground truth" is typically defined by engineering standards, physical measurements, and established biomechanical principles rather than expert consensus, pathology, or clinical outcomes data. For example, the ground truth for "femoral stem fatigue testing" would be the point of failure or the ability to withstand a specified number of cycles at a given load according to an ASTM or ISO standard.

8. The sample size for the training set

Not Applicable (N/A): This is a mechanical device, not an AI/ML system that uses a "training set."

9. How the ground truth for the training set was established

Not Applicable (N/A): See #8.

Summary

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510(K) SUMMARY

DEC 2 8 2012

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长121297

Manufacturer:	Signature Orthopaedics Pty Ltd126 Greville StreetChatswood, NSW 2067Australia
Device Trade Name:	Origin™ Total Hip System
Common Name:	Total Hip Prosthesis
Contact:	Dr. Declan BrazilManaging Director of Signature Orthopaedics
Prepared By:	Signature Orthopaedics Pty Ltd126 Greville StreetChatswood, NSW 2067AustraliaPhone: (011) 61 (2) 9419 4105Fax: (011) 61 (2) 4271 8021
Date Prepared:	April 20th, 2012
Classification:	Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncemented prosthesis(MEH)Class II per 21 CFR 888.3358: Hip joint metal/polymer/metalsemi-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 ·

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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:

· 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.

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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.

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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

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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 (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

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

Regulation Number and Section

§ 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.