The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.

• Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.

The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.

• Reverse Shoulder Prosthesis – monobloc stem

The reverse shoulder prosthesis using the standard monobloc stem is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

The reverse shoulder prosthesis using the short monobloc stem is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.

• Anatomic Shoulder Prosthesis – monobloc stem

The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.

Device Description

The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:

Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
Monobloc stem spacer small and large;
Monobloc stem double eccenter small and large;
Monobloc stem spacer/double eccenter screw;
Distal screws with lengths from 18 to 36 in 2mm steps;
Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
Humeral reverse metaphysis small concentric and eccentric.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - MSS Monobloc Stem

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.03

February 3, 2026

Medacta International S.A.
℅ Christopher Lussier
Senior Director, Quality, Regulatory
Medacta USA
6386 Global Drive, Suite 101
Memphis, Tennessee 38141

Re: K250644
Trade/Device Name: MSS - Monobloc stem
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX, KWS, HSD
Dated: January 29, 2026
Received: January 29, 2026

Dear Christopher Lussier:

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 (the 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 available 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.

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K250644 - Christopher Lussier Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250644 - Christopher Lussier Page 3

assistance/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,

Farzana Sharmin -S

Farzana Sharmin, PhD
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250644

Device Name: MSS - Monobloc stem

Indications for Use (Describe)

• Reverse Shoulder Prosthesis

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.

• Anatomic Shoulder Prosthesis

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.

Page 5

• Reverse Shoulder Prosthesis – monobloc stem

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.

• Anatomic Shoulder Prosthesis – monobloc stem

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Page 6

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, including 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."

Page 7

MSS – Monobloc stem Medacta International SA

Traditional 510(k) K250644 Page 1 of 6

510(k) Summary

I. Submitter

Medacta International SA
Strada Regina
6874 Castel San Pietro (CH)
Switzerland
Phone (+41) 91 696 60 60
Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA
Applicant Correspondent: Chris Lussier, Senior Director, Quality, Regulatory, Medacta USA
Date Prepared: March 04, 2025
Date Revised: January 3rd, 2026

II. Device

Device Proprietary Name:	MSS – Monobloc stem
Common or Usual Name:	Shoulder prosthesis, reverse configuration
Classification Name:	Shoulder joint metal/polymer semi-constrained cemented prosthesis
Primary Product Code	PHX
Secondary Product Code	KWS, HSD
Regulation Number:	21 CFR 888.3660, 21 CFR 888.3690
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following predicate devices.

Primary Predicate device:

Medacta Shoulder System, K170452, Medacta International SA

Additional Predicate devices:

FX V135™ Shoulder Prosthesis, K223801, FX Shoulder USA, Inc
FX V135™ Shoulder Prosthesis, K213117, FX Shoulder USA, Inc
Medacta Anatomic Shoulder Prosthesis, K170910, Medacta International SA
Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International SA
Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA
Humeral Eccentric Reverse Metaphysis, K210207, Medacta International SA
INHANCE Reverse Shoulder System, K212737, Depuy Ireland UC
HUMELOCK II Cementless shoulder system, K130759, Fx Solutions

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MSS – Monobloc stem Medacta International SA
Traditional 510(k) K250644 Page 2 of 6

Reference devices:

GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE), K202022, Medacta International SA
Mpact 3D Metal implants – DMLS Technology, K202568, Medacta International SA

IV. Device Description

The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:

Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
Monobloc stem spacer small and large;
Monobloc stem double eccenter small and large;
Monobloc stem spacer/double eccenter screw;
Distal screws with lengths from 18 to 36 in 2mm steps;
Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
Humeral reverse metaphysis small concentric and eccentric.

V. Indications for Use

○ Reverse Shoulder Prosthesis

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.

○ Anatomic Shoulder Prosthesis

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MSS – Monobloc stem Medacta International SA
Traditional 510(k) K250644 Page 3 of 6

an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.

○ Reverse Shoulder Prosthesis – monobloc stem

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.

○ Anatomic Shoulder Prosthesis – monobloc stem

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

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MSS – Monobloc stem Medacta International SA
Traditional 510(k) K250644 Page 4 of 6

The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.

VI. Comparison of Technological Characteristics

The subject and predicate devices (K170452, K170910, K180089, K210207, K223801 and K213117) are substantially equivalent with respect to the following characteristics:

Monobloc stem design;
Stem sizes;
Stem fixation;
Stem and liners inclination;
Liners articular surface diameter;
Liners and spacers height;
Liners jump height;
Double eccenters and metaphysis eccentricity;
Coating, if applicable;
Biocompatibility;
Device usage;
Packaging;
Shelf-life; and
Sterilization.

The subject devices differ from the predicate devices (K170452, K170910, K180089, K210207, K223801 and K213117) with respect to:

Stem lengths;
Stem coated area
Stem suture hole;
Liners coupling with the metaphysis;
Metaphysis diameter;
Spacers and double eccenters sizes; and
3D Metal short stem as well as E-Cross liners materials.

The subject distal screws are substantially equivalent to the predicate Humelock II Cementless Shoulder System – cortical screws (K130759) with respect to the main technological features.

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MSS – Monobloc stem Medacta International SA
Traditional 510(k) K250644 Page 5 of 6

Discussion

The subject monobloc stem lengths are partially different with respect to the predicate devices but this difference has no impact on safety and effectiveness since the subject devices' lengths is included in the range of Medacta predicate devices (K170452, K170910 and K180089).

The slightly different stem coated area between the subject and predicate devices does not raise any different questions of safety and effectiveness since the subject devices coated area percentage is within the range of Medacta predicate devices (K170452, K170910 and K180089).

The partially different suture holes of the subject monobloc stems respect to the predicate devices (K170452, K170910, K180089, K223801 and K213117) do not introduce any different questions with regards to safety and effectiveness since both the subject predicate devices have lateral and medial holes.

The tabs on the subject humeral reverse liners small and large have the same objective of the peg on Medacta humeral reverse liners cleared within K170452 without raising any different questions of safety and effectiveness.

The subject small humeral reverse metaphysis diameter does not affect safety and effectiveness since it is in the range of the predicate device, INHANCE Reverse Shoulder System (K212737).

The availability of two different sizes of spacers and double eccenters is strictly related to the two different metaphysis diameters designed on the subject monobloc stem, thus it has not any impact on safety and effectiveness.

The 3D metal version of the short stem as well as the E-cross version of humeral reverse liners small and large do not affect safety and effectiveness since the materials as well as the manufacturing processes are shared with the reference devices cleared within K202568 and K202022, respectively.

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices respect to the predicate devices.

VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests are provided in support of the substantial equivalence determination:

Non-Clinical Studies

○ DESIGN VALIDATION

Monobloc stem design validations
Small humeral reverse metaphysis: assessment of design and dimensions
Small humeral reverse metaphysis: coupling assessment

○ PERFORMANCE TESTING

Lever-out strength of Humeral Reverse Liner - Small & Large
Push-out strength of Humeral Reverse Liner - Small & Large
Torsional strength of Humeral Reverse Liner - Small & Large
Mechanical fatigue test on 3D Metal monobloc humeral reverse stemmed construct
Mechanical fatigue test on 3D Metal monobloc humeral anatomic stemmed construct
Mechanical fatigue test on monobloc humeral reverse and anatomic stemmed construct

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MSS – Monobloc stem Medacta International SA
Traditional 510(k) K250644 Page 6 of 6

Coupling strength of monobloc stem double eccenter
Monobloc stem ROM assessment according to ASTM F1378-18e1
Rationale for tensile and shear tests of the pyramidal net
Mechanical fatigue testing on humeral reverse stemmed constructs with small reverse metaphysis
Mechanical Wear Test on the Medacta Shoulder System - Reverse with Humeral Reverse Liner Constrained
Distal screw static tests
Mechanical fatigue test on distal screws for monobloc stem
Characterization report for Titanium + Hydroxyapatite double coating on monobloc stem in terms of roughness, thickness, porosity, sandblasting pollution and static tensile strength
Cross sectioned area of the Titanium + Hydroxyapatite implant surfaces of the Medacta monobloc stem
SEM pictures of the Titanium + Hydroxyapatite implant surfaces of the Medacta monobloc stem
XRD analyses comparing features of the Hydroxyapatite coating deposed on the Medacta monobloc stem and on planar samples
Rationale: Extension of the sizes for the humeral reverse metaphysis coating characterization

○ PYROGENICITY

Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
Pyrogen test according to USP chapter <151> for pyrogenicity determination
The subject devices are not labeled as non-pyrogenic or pyrogen free.

○ BIOCOMPATIBILITY assessment

○ SHELF-LIFE evaluation

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the subject devices are substantially equivalent to the predicate device.

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.”