LogoFDA 510(k) Search
K Number
K251558

Validate with FDA (Live)

Device Name
Precision AI Surgical Planning System (PAI-SPS)
Manufacturer
Precision AI Pty, Ltd.
Date Cleared
2026-01-12

(236 days)

Product Code
QHE,KWS,PHX
Regulation Number
888.3660
Type
Traditional
Panel
Orthopedic
Age Range
18 - 90
Reference & Predicate Devices
K222405,K243955,K193560,K242813
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Software

The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware

The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.

The Precision AI Guides and Biomodels are indicated for single use only.

The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:

Enovis:

Lima:

Device Description

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following:

  • The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operation preoperatively. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The software will create patient-specific Guide CAD file(s) if requested by the surgeon.

  • The Precision AI Guides, which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides and models will be manufactured using 3D printing by selective laser sintering if the surgeon requests patient-specific guides to transfer the plan to surgery.

The PAI-SPS generates a pre-surgical plan based on medical imaging data using the PAI-SPS Software. The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The PAI-SPS Software allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, PAI-SPS Guides and Models are designed and manufactured based on the approved pre-surgical plan. PAI-SPS Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid/humeral components used with total and reverse shoulder arthroplasty procedures.

AI/ML Overview

The provided 510(k) clearance letter for the PAI-SPS does not contain specific acceptance criteria or details of a study proving the device meets said criteria in the format requested. The document primarily focuses on the regulatory clearance process, device description, and comparison to predicate devices, stating that clinical testing was not required to demonstrate substantial equivalence.

However, based on the information provided, we can infer some aspects and highlight what is missing.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

  • Acceptance Criteria: Not explicitly stated in terms of measurable thresholds (e.g., minimum accuracy percentages, error margins). The document implies that the acceptance criteria relate to demonstrating "substantial equivalence" in safety and effectiveness compared to predicate devices.
  • Reported Device Performance: No specific numerical performance metrics are reported. The document states that "Software verification and validation" and "Usability validation" were completed to demonstrate substantial equivalence.
Acceptance Criteria (Inferred from regulatory context)Reported Device Performance (Summary from submission)
Device is substantially equivalent in safety and effectiveness to predicate devices.Demonstrated through comparison of intended use, design, and technological characteristics.
Software functions as intended and safelySoftware verification and validation completed.
Device is usable by intended users without undue riskUsability validation completed.
Hardware design and materials are appropriate for intended useSubstantially equivalent in intended use, design, functionality, operating principles, and materials compared with primary predicate.

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

  • Sample Size: Not specified. The document does not mention a specific "test set" in the context of clinical or performance data using patient-specific samples.
  • Data Provenance: Not specified. As clinical testing was not required for substantial equivalence, there's no mention of country of origin or whether data was retrospective or prospective.

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

  • Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for a test set. The validation efforts mentioned (software V&V, usability validation) do not typically involve this type of ground truth establishment.

4. Adjudication method for the test set

  • Not applicable/Not specified. Since no expert-established ground truth test set is described, an adjudication method is not mentioned.

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

  • No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." Therefore, an MRMC comparative effectiveness study was not performed or submitted for this clearance.

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

  • Yes, implicitly. The "Software verification and validation" would have involved testing the algorithm's performance in generating the 3D construct and patient-specific guide files. While specific metrics are not provided, this validation inherently assesses the algorithm's standalone capabilities. The software "auto segments via a locked, or static, artificial intelligence algorithm."

7. The type of ground truth used

  • For the AI algorithm (segmentation): Implicitly, the ground truth for the segmentation algorithm would have been expert-annotated CT images or established anatomical landmarks against which the AI's segmentation accuracy is measured during its development and internal validation. The document does not specify how this ground truth was established, only that the AI algorithm is "locked, or static."
  • For the overall system: The ground truth for the planning software and guides would be the "optimal position" for implant placement as determined by a qualified surgeon. The system's goal is to assist in achieving this optimal position.

8. The sample size for the training set

  • Not specified. The document mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained on a dataset, but the size of this training set is not provided.

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

  • Not specified. While it's implied that the AI for auto-segmentation was trained using data with established ground truth (likely expert-defined anatomical structures on CT images), the methodology for establishing this ground truth is not detailed in the clearance letter.

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

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

Doc ID # 04017.08.02

January 12, 2026

Precision AI Pty Ltd
℅ Stefanie Auf Der Mauer
Regulatory Affairs Consultant
Stefanie Michele Auf der Mauer Asmuss
22 Monfield
Rochestown, Cork T12C65D
Ireland

Re: K251558
Trade/Device Name: Precision AI Surgical Planning System (PAI-SPS)
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: QHE, PHX, KWS
Dated: December 12, 2025
Received: December 12, 2025

Dear Stefanie Auf Der Mauer:

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.

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"

Page 2

K251558 - Stefanie Auf Der Mauer Page 2

(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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-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).

Page 3

K251558 - Stefanie Auf Der Mauer Page 3

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)
K251558

Device Name
Precision AI Surgical Planning System (PAI-SPS)

Indications for Use (Describe)

Software

The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware

The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.

The Precision AI Guides and Biomodels are indicated for single use only.

The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:

Enovis:

Lima:

Page 5

  • SMR Stemless Anatomic (K221758)
  • SMR 140° Reverse Humeral Body (K201905)
  • SMR TT Augmented Glenoid System (K191746, K200171)
  • SMR Lateralized Connectors with screws (K183042)
  • SMR TT Augmented 360 Baseplate (K220792)
  • SMR TT Hybrid Glenoid (K220792)
  • PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)
  • PRIMA TT Glenoid (K222427)

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.

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 6

K251558 - Page 1 of 5

510(K) SUMMARY

Prepared: January 12, 2026

1 Applicant Details

Name:Precision AI Pty Ltd
Address:Suite 18, 36 Agnes StreetFortitude Valley QLD 4006Australia
Contact Person:Katrina DombováriSenior Regulatory Affairs SpecialistEmail: katrina.dombovari@enovis.comPhone: +12507136196
Correspondent:Stefanie Auf der MauerEmail: stefanie.aufdermauer@enovis.comPhone: +353 85 759 1774

2 Subject Device Details

Device Trade Name:Precision AI Surgical Planning System (PAI-SPS)
Device Common Name:Surgical Planning Software and Patient Specific Guide
Regulation:21 CFR 888.3660Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class:II
Product Code(s):QHE - Shoulder Arthroplasty Implantation SystemPHX, KWS

Page 7

K251558 - Page 2 of 5

3 Predicate and Reference Devices

Primary Predicate Device

510(k) Number:K243955
Device Trade Name:Precision AI Surgical Planning System (PAI-SPS)
Submitter:Precision AI Pty Ltd
Product Code(s):QHE - Shoulder Arthroplasty Implantation SystemKWS, PHX

Predicate Device

510(k) Number:K193560, K242813
Device Trade Name:Materialise Shoulder System, SurgiCase Shoulder Planner
Submitter:Materialise N.V.
Product Code(s):QHE - Shoulder Arthroplasty Implantation SystemKWS, PHX

Reference Device

510(k) Number:K222405
Device Trade Name:SmartSPACE Shoulder System, SmartSPACE Shoulder Planner and 3D Positioners
Submitter:LimaCorporate S.p.A
Product Code(s):QHE - Shoulder Arthroplasty Implantation SystemKWS, MBF

4 Device Description Summary

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following:

  • The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operation preoperatively. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position

Page 8

K251558 - Page 3 of 5

to correct the measured deformity for that specific patient. The software will create patient-specific Guide CAD file(s) if requested by the surgeon.

  • The Precision AI Guides, which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides and models will be manufactured using 3D printing by selective laser sintering if the surgeon requests patient-specific guides to transfer the plan to surgery.

The PAI-SPS generates a pre-surgical plan based on medical imaging data using the PAI-SPS Software. The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The PAI-SPS Software allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, PAI-SPS Guides and Models are designed and manufactured based on the approved pre-surgical plan. PAI-SPS Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid/humeral components used with total and reverse shoulder arthroplasty procedures.

5 Intended Use and Indications for Use

Software

The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware

The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.

The Precision AI Guides and Biomodels are indicated for single use only.

The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:

Enovis:

Page 9

K251558 - Page 4 of 5

Lima:

6 Comparison of Technological Characteristics

The subject device PAI-SPS has an identical intended use and indications for use as the previously cleared primary predicate (K243955).

Software

The subject device's software has the same technological characteristics as the primary predicate, apart from an optional anatomical shape reconstruction feature. The predicate device SurgiCase Shoulder Planner has an equivalent feature. The subject software technological difference has been demonstrated to not affect safety or effectiveness or raise different questions of safety and effectiveness.

Hardware

The subject device's hardware is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the primary predicate.

7 Performance Data (non-clinical)

The following performance tests were completed to demonstrate substantial equivalence of safety and effectiveness:

  • Software verification and validation following the Guidance "Premarket Submissions for Device Software Functions" and "General Principles of Software Validation"
  • Usability validation following the Guidance "Applying Human Factors and Usability Engineering to Medical Devices"

Clinical testing was not required to demonstrate substantial equivalence.

Page 10

K251558 - Page 5 of 5

8 Conclusion

Data presented in this submission demonstrates that PAI-SPS is substantially equivalent to the predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.

§ 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.”