A replacement of shoulder joints in primary anatomic or in primary reverse.
A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

IN ANATOMIC: The stem and head by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

Rheumatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
Revision of other devices if sufficient bone stock remains

IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis; Noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis); Correction of functional deformity; Fractures of the humeral head; Traumatic arthritis; Revision of the devices if sufficient bone stock remains.

The reversed adapter is indicated for use as components of the Shoulder System total shoulder replacement and for transformation of the Aequalis Assend Flex Shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropatly is associated with a massive and non-repairable rotator cuff-tear.

Device Description

The Aequalis Ascend Flex Shoulder System consists of:

In a Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (COCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) . coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants.
The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert.
The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere; made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear. This submission corresponds to the addition of Titanium Humeral Heads in anatomic to the Aequalis™ Ascend™ Flex Shoulder System.

AI/ML Overview

The provided document is a 510(k) Summary for the Aequalis™ Ascend™ Flex Shoulder System, focusing on the addition of Titanium Humeral Heads. This type of regulatory submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comprehensive study in the way an AI/ML device would be evaluated.

Therefore, the requested information, which is typically relevant for AI/ML device evaluations involving clinical performance studies and ground truth establishment, is largely not applicable to this document. The document describes non-clinical (bench) testing to demonstrate mechanical equivalence, not clinical performance or diagnostic accuracy.

However, I can extract the relevant information the document does provide and indicate where the requested information is not present or not applicable.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in a quantitative manner as one would for diagnostic accuracy metrics (e.g., sensitivity, specificity thresholds). Instead, "device performance" is demonstrated through non-clinical (bench) testing, showing equivalence to predicate devices under simulated conditions.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Wear Test	Titanium humeral head remains intact during its lifetime. Wear of new Ti/UHMWPE frictional couple is equivalent to predicate CoCr/UHMWPE frictional couple.	Equivalent results between Ti/UHMWPE and CoCr/UHMWPE in terms of: weight loss, wear rate, and shape/size of generated particles.
Anatomical Fatigue Test	Aequalis™ Ascend Flex Shoulder System (anatomical configuration with Titanium humeral head) remains intact during its lifetime, resisting load for 5M cycles without fracture or damage.	No fracture or damage observed after applying a load for 5 million cycles. Validated with titanium humeral head, similar to CoCr humeral head (predicate).
Reversed Fatigue Test	Aequalis™ Ascend Flex Shoulder System (reversed configuration after revision from anatomical to reversed, with Titanium humeral head) remains intact during its lifetime after 5M cycles without fracture or damage.	No fracture or damage observed after applying a load for 5 million cycles. Validated with titanium humeral head, similar to CoCr humeral head (predicate).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable in the context of clinical studies for diagnostic AI/ML. The tests mentioned are bench tests on physical devices/components. The sample size would refer to the number of physical samples tested, which is not specified in the summary document but would be detailed in the full test reports.
Data provenance: Not applicable. The data comes from non-clinical bench testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in this context is established by the physical testing and material properties, not by expert interpretation of data.

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

Not applicable. This refers to expert consensus for clinical image interpretation, not mechanical testing.

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. This is for AI/ML diagnostic devices, not shoulder prosthetics.

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

Not applicable. This is for AI/ML diagnostic devices, not shoulder prosthetics.

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

The "ground truth" for these tests are the material properties and mechanical performance under specified conditions, determined by standardized test methodologies (e.g., ISO standards, and documented internal test protocols). The assessment is based on physical observation (e.g., absence of fracture, damage) and quantitative measurements (e.g., wear rate, weight loss), not clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm being trained here.

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

Not applicable. There is no AI/ML algorithm being trained here.

In summary, this 510(k) submission demonstrates the safety and effectiveness of a medical device (shoulder prosthesis component) through non-clinical (bench) testing, showing its equivalence to legally marketed predicate devices. The framework for describing acceptance criteria and studies for AI/ML devices is not directly applicable to this type of traditional medical device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Tornier SAS Mr. Aymen Azaiez Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Cedex FRANCE

Re: K140082

Trade/Device Name: Aequalis™ Ascend™ Flex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, HSD Dated: June 17, 2014 Received: June 19, 2014

Dear Mr. Azaiez:

This letter corrects our substantially equivalent letter of July 18, 2014.

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 - Mr. Aymen Azaiez

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) Ki40082

Device Name

AequalisTM AscendTM Flex Shoulder System

Indications for Use (Describe)

SYSTEM INTENDED USE:

The Aequalis Ascend Flex Shoulder System is intended for use as:

· A replacement of shoulder joints in primary anatomic or in primary reverse.

· A replacement of other shoulder ioints devices in case of revisions if sufficient bone stock remains.

· The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

IN ANATOMIC: The stem and head by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

· Rheumatoid arthritis with pain

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascu Jar necrosis)

· Correction of functional deformity

· Fractures of the humeral head

· Traumatic arthritis

· Revision of other devices if sufficient bone stock remains

Notes: All components are single use. The coated humeral stem is intented or cementless use, The non-coated humeral stem is intended for cemented use only, All poly glenoid components are intended use only; The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Type of Use (Select one or both, as applicable) O Over-The-Counter Use (21 CFR 801 Subpart C) Prescription Use (Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.•

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, induding suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. -

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510(k) SUMMARY

JUL 1 8 2014

Summary of Safety and Effectiveness information

510(k) Premarket Notification - Aequalis™ Ascend™ Flex Shoulder System

Date prepared: July 17, 2014

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name

Trade name: Aequalis™ Ascend™ Flex Shoulder System Common name: Shoulder Prosthesis Classification name:

Classification name.

Shoulder joint metal/polymer non-constrained
· Shoulder joint metal/polymer non-constrained cemented prosthesis are class II devices under 21 CFR 888.3650 (product code KWT) and are classified by the Orthopedic Devices Panel
· Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) and are classified by the Orthopedic Devices Panel
· Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel

2) Submitter

TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034

3) Company contact

Tornier Mr Aymen AZAIEZ Regulatory Affairs Specialist Tornier 161 rue Lavoisier 38330 Montbonnot Saint Martin- France

Fax: 00 33 4 76 61 35 59 Tel: 00 33 4 76 61 35 00 E-mail: aymen.azaiez@tornier.com

4) Classification

Device class: Classe II Classification panel: Orthopedic Product code: KWT; KWS; HSD:

5) Equivalent / Predicate device

Tornier SAS: Aequalis™ Ascend™ Flex Shoulder System (K122698)

Tornier SAS: Aequalis® Shoulder System (K952928)

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K 140082 Page 2 of 5

6) Device description

The Aequalis Ascend Flex Shoulder System consists of:

. In a Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (COCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) . coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants.

The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert.

The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere; made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear. This submission corresponds to the addition of Titanium Humeral Heads in anatomic to the Aequalis™ Ascend™ Flex Shoulder System.

7) Materials

The Aequalis™ Ascend™ Flex Shoulder System titanium humeral head is manufactured from Ti6Al/4 according to ISO 5832-3 standard.

8) Indications for use

SYSTEM INTENDED USE:

The Aequalis Ascend Flex Shoulder System is intended for use as:

A replacement of shoulder joints in primary anatomic or in primary reverse. .
A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. .
The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

IN ANATOMIC: The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff. where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled bv:

Rheumatoid arthritis with pain .
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
Correction of functional deformity .
Fractures of the humeral head .
Traumatic arthritis ●
Revision of other devices if sufficient bone stock remains .

Rheumatoid arthritis .

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Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
. Correction of functional deformity
Fractures of the humeral head .
Traumatic arthritis ●
Revision of the devices if sufficient bone stock remains .

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle: the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

Notes:

All components are single use. .
The coated humeral stem is intended for cemented or cementless use. .
The non-coated humeral stem is intended for cemented use only. .
All poly glenoid components are intended for cemented use only. .
The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. .
· · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

9) Summary of technological characteristics

Main features or systemcharacteristics		Aequalis Ascend Flex ShoulderSystemHumeral Heads (titanium)		Aequalis Ascend Flex ShoulderSystemHumeral Heads (Cobalt Chrome)		AequalisShoulderSystemAequalisHumeral Heads	SE?
		AequalisHumeralHeads	Soft TissueBalancing(STB) HumeralHeads	AequalisHumeralHeads	Soft TissueBalancing(STB) HumeralHeads
Material		Ti6Al4V		CoCr		Ti6Al4V	Yes
Standard		ISO 5832-3		ISO 5832-7 orISO 5832-12		ISO 5832-3	Yes
Dimensions	Diameter	37mm to54mm	39mm to55.4mm	37mm to54mm	39mm to55.4mm	39mm to50mm	Yes
	Height	13.5mm to27mm	13mm to24mm	13.5mm to27mm	13mm to24mm	14mm to16mm	Yes
	Eccentricity	1.5mm; 3.5mm and 4mm		1.5mm; 3.5mm and 4mm		2mm; 2.2mm;2.3mm;3mm;3.9mm et4.7mm	Yes
Taper gender geometry		Male		Male		Female	Yes
Manufacturer		Tornier		Tornier		Tornier	Yes
Terminal sterilization		Yes		Yes		Yes	Yes
K-number		Pending		K122698		K952928	Yes

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K140082 Page 4 of 5

The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of they are similar or identical to the predicate devices.

10) Non-clinical testing

Three non-clinical testing were realized on the titanium humeral heads:

Wear test:
The aim of the test is to demonstrate that the Titanium humeral head remain intact during its lifetime. Therefore, we have tested the wear of the frictional couple Ti / UHMWPE and compared the results with those of the frictional couple CoCr/UHMWPE.

The results of this test are equivalent between the two frictional couples CoCr / UHMWPE (already used in the predicate device "Aequalis Ascend Flex Shoulder System") and TI / UHMWPE in terms of: weight loss, wear rate and shape and size of the particles generated.

Anatomical Fatigue Test:

The aim of the test is to show that the AequalisTM Ascend Flex Shoulder System in anatomical configuration remains intact during its lifetime. The assembly humeral head/ stem must resist in normal conditions of use.

After applying a load for SM cycles, we have observed neither fracture nor damage. Thus, the Aequalis™ Ascend Flex Shoulder System in anatomical configuration is validated with the titanium humeral head as is the case with the CoCr humeral head (predicate device).

Reversed fatique test: -

The aim of the test is to show that the Aequalis™ Ascend Flex Shoulder System in reversed configuration remains intact during its lifetime after revision from an anatomical configuration to a reversed configuration after a first lifetime in an anatomical configuration. The assembly humeral headl stem must resist in normal conditions of use.

After applying a load for SM cycles. we have observed neither fracture nor damage. Thus, the Aequalis™ Ascend Flex Shoulder in reversed configuration after revision from an anatomical configuration to a reversed configuration after a first lifetime in anatomical configuration with the titanium humeral head is validated as is the case with the CoCr humeral head (predicate device).

11) Substantial equivalence conclusion

Substantial equivalence of the Aequalis Ascend Flex Shoulder System titanium humeral heads to the already cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:

The Aequalis Ascend Flex Shoulder System titanium humeral heads are compared to the predicate . devices.
The Aequalis Ascend Flex Shoulder System Tianium humeral heads have the same intended use and l the same indications for use as the cleared Aequalis Ascend Flex Shoulder System Cobals Chrome humeral heads.
The Aequalis Ascend Flex Shoulder System titanium humeral heads have equivalent intended use and indications for use as Aequalis Shoulder System Aequalis Humeral Head in titunium.

Tomier

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Major technological characteristics are equivalent between the Aequalis Ascend Flex Shoulder System titanium humeral heuds and the predicate devices:
- Equivalence of general features -
- Equivalent technological features: materials •
- Equivalent biomechanical features: mechanical characteristics, congruence of articular surfaces.
- Equivalent means of fixation (Taper gender geometry) -
- Equivalent prosthetic dimensions -

Therefore, in light of the above information, the company believes that the Aequalis Ascend Flex Shoulder System with itanium humerul heads may be cleared via the 510(k) notification process for use as shoulder prosthesis.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”