ASTM F2028-25 PDF

Full title and description

St ASTM F2028-25 — Standard Test Methods for Dynamic Evaluation of Glenoid Loosening. This ASTM F04 series test method describes dynamic (cyclic) test procedures to quantify rocking, pivoting, and displacement of prosthetic glenoid components (anatomic and reverse designs) under simulated articulation with a mating humeral component to evaluate resistance to loosening and potential for disassociation.

Abstract

ASTM F2028-25 defines laboratory test methods that simulate edge-loading (“rocking‑horse”) conditions to measure the magnitude of motion (displacement) of anatomic glenoid components and reverse glenoid baseplates during dynamic articulation. The methods are intended for use in design comparison, ranking of devices, and detection of design-related loosening risks for cemented and uncemented fixations. The standard reports test setup, measurement points, and reporting conventions; values are stated in SI units.

General information

• Status: Active (current ASTM designation F2028-25; distributor listings also reference an amended designation F2028-25a).
• Publication date: Last updated / published in 2025 — primary ASTM document shows last update 25 August 2025 (some commercial listings report nearby publication dates such as 15 Aug 2025 or 15 Jun 2025). Users should confirm the exact revision date on the ASTM record before purchase.
• Publisher: ASTM International (Committee F04, Subcommittee F04.22 on Arthroplasty).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics (medical device test methods).
• Edition / version: F2028-25 (references and listings also note an amendment/version F2028-25a).
• Number of pages: 15 pages (document length reported as 15 pages in ASTM product summary).

Scope

The standard measures how much a prosthetic anatomic glenoid component rocks or pivots after dynamic displacement of a mating humeral head between opposing glenoid rims, and how much a reverse glenoid baseplate rocks or pivots after cyclic articulation with a humeral liner. It applies to monolithic and modular anatomic glenoids (cemented fixation) and reverse glenoid baseplates (typically uncemented with screws). The method is intended for comparative testing and ranking of device designs; all values are reported in SI units.

Key topics and requirements

• Dynamic (cyclic) test setups to reproduce edge-loading / rocking‑horse conditions and quantify resulting displacement.
• Measurement of displacement/motion opposite each loaded rim (pre- and post‑dynamic articulation) as the primary performance metric.
• Applicability to anatomic glenoids (cemented) and reverse glenoid baseplates (uncemented, screw‑fixation).
• Test variables that affect outcomes: articular geometry, flange geometry, materials, fixation design, bone surrogate quality, and surgical technique — users must control and report these factors.
• Use of SI units and adherence to referenced general practices (for example, related measurement and equipment accuracy practices cited within the standard).

Typical use and users

Device manufacturers (design and verification teams), independent biomechanics test laboratories, pre‑clinical research groups, regulatory submission teams, and quality/test engineers use F2028-25 to evaluate and compare glenoid component designs for susceptibility to loosening or disassociation under simulated physiological rocking loads. Results are commonly used in internal design decisions, test reports supporting regulatory filings, and comparative benchmarking.

Related standards

F2028 is part of a lineage of ASTM test methods for glenoid evaluation (previous editions include F2028-02, F2028-05, F2028-08, F2028-14, and F2028-17). The document also references other ASTM general practices and test methods (for instrumentation and load/measurement practices) and sits within Committee F04 on Medical and Surgical Materials and Devices. Users should consider related implant and fatigue test standards when designing a test program.

Keywords

glenoid loosening, dynamic evaluation, rocking‑horse, glenoid baseplate, anatomic glenoid, reverse glenoid, shoulder arthroplasty, cyclic testing, ASTM F2028, implant testing, F04.22.

FAQ

Q: What is this standard?

A: ASTM F2028-25 is a test-method standard that defines dynamic (cyclic) laboratory procedures to evaluate how prosthetic glenoid components (anatomic and reverse) move under rocking/edge‑loading conditions and to quantify displacement that indicates loosening or risk of disassociation.

Q: What does it cover?

A: It covers test setup, cyclic articulation conditions, measurement and reporting of displacement (motion) opposite loaded rims, and applicability to monolithic/modular anatomic glenoids (cemented) and reverse glenoid baseplates (uncemented with screws). The standard is intended primarily for device comparison and ranking.

Q: Who typically uses it?

A: Medical device manufacturers (design and verification), biomechanics and materials test laboratories, preclinical researchers, and regulatory or quality teams use these methods for design evaluation, verification testing, and supporting documentation for submissions.

Q: Is it current or superseded?

A: As of the document record, F2028-25 is the current ASTM designation published/updated in 2025; some commercial listings and supplier entries reference an amendment/version F2028-25a (amendments dated in Aug 2025). There is also an active subcommittee work item (WK95222) documenting editorial/revision activity to clarify specific clauses — users should confirm the exact effective designation and amendment history on the ASTM document record before relying on a single version.

Q: Is it part of a series?

A: Yes — F2028 belongs to ASTM Committee F04 (Medical and Surgical Materials and Devices) under Subcommittee F04.22 (Arthroplasty). It is one of a series of F‑standards addressing implant test methods and prosthetic component evaluation (earlier and related editions include F2028-02, F2028-05, F2028-08, F2028-14, and F2028-17).

Q: What are the key keywords?

A: Glenoid loosening, rocking‑horse, cyclic testing, displacement measurement, anatomic glenoid, reverse glenoid baseplate, shoulder arthroplasty testing, implant verification, ASTM F2028.