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FDA product code · Orthopedic · Class 2

LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

LZO is FDA's product code for "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented": a Class 2 device classified under 21 CFR 888.3353, reviewed by the Orthopedic panel. FDA flags it as an implant.

510(k) review time for LZO

Across 130 510(k) clearances under LZO decided from 2018-01-01 to 2026-10-06, the median was 133 days from FDA receipt to decision. Half took between 77 and 244 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LZO, decisions 2018-01-01 to 2026-10-06 (n = 130)
Fastest11
25th percentile77
Median133
75th percentile244
80th percentile261
90th percentile305
Slowest530
Median days by decision year, LZO (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
201816318
201910928
202011218
202117012
202227911
202312210
202411111
202511914
2026 (to 10-06, partial)1078

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.

LZO in the public FDA record

Records naming LZO, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years533
Device recalls177
Establishment listings2,824
GUDID device identifiers32,067

Counts of records, not of devices or events. Adverse event reports for LZO 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 LZO

64 FDA recognized consensus standards cite LZO, among them ASTM F1875-98 (Reapproved 2022); ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 11-183 ASTM F1875-98 (Reapproved 2022) — Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
  • 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
  • 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • 11-272 ASTM F1714-96 (Reapproved 2025) — Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
  • 11-277 ISO 7206-6 Second edition 2013-11-15 — Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
  • 11-307 ASTM F2385-15 (Reapproved 2024) — Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
  • 11-312 ISO 7206-4 Third edition 2010-06-15 — Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
  • 11-314 ISO 14242-2 Second edition 2016-09-15 — Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
  • 11-319 ISO 7206-12 First edition 2016-10-01 — Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
  • 11-337 ISO 16087 First edition 2013-10-01 — Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
  • 11-338 ISO 11491 First edition 2017-07 — Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
  • 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 — Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic ceramic and plastics materials [Including AMENDMENT1 (2016) ]
  • 11-342 ASTM F732-17 (Reapproved 2025) — Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
  • 11-344 ASTM F2580-18 — Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
  • 11-349 ISO 14242-3 First edition 2009-03-15 — Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]

The first 15 of 64 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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