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FDA product code · Orthopedic · Class 2

PHX: Shoulder Prosthesis, Reverse Configuration

PHX is FDA's product code for "Shoulder Prosthesis, Reverse Configuration": a Class 2 device classified under 21 CFR 888.3660, reviewed by the Orthopedic panel. FDA flags it as an implant.

510(k) review time for PHX

Across 109 510(k) clearances under PHX decided from 2018-01-01 to 2026-10-06, the median was 139 days from FDA receipt to decision. Half took between 72 and 198 days, and 80% were decided within 218 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PHX, decisions 2018-01-01 to 2026-10-06 (n = 109)
Fastest20
25th percentile72
Median139
75th percentile198
80th percentile218
90th percentile267
Slowest496
Median days by decision year, PHX (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
201812714
20191449
202014313
202114321
20221989
20231549
20241399
2025729
2026 (to 10-06, partial)13316

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

PHX in the public FDA record

Records naming PHX, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years205
Device recalls68
Establishment listings1,277
GUDID device identifiers7,120

Counts of records, not of devices or events. Adverse event reports for PHX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite PHX

8 FDA recognized consensus standards cite PHX, 2 of them recognized only in part, among them ASTM F2028-17; ASTM F2028-25a; ISO 5834-3 Second edition 2019-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 11-330 ASTM F2028-17 (partial recognition) — Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
  • 11-433 ASTM F2028-25a (partial recognition) — Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
  • 8-495 ISO 5834-3 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
  • 8-496 ISO 5834-4 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
  • 8-497 ISO 5834-5 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
  • 8-501 ISO 5834-1 Fourth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
  • 8-514 ISO 5834-2 Fifth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
  • 8-572 ASTM F2565-21 — Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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