510(k) Report

FDA applicant

Lima Corporate S.P.A.

Villanova Di San Daniele Del Friuli, IT64 decisions2011–202613 recalls

FDA records 64 decisions for Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT) from 2011 to 2026: 64 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 275 predicates, 93 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Lima Corporate S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2011: 42012: 52013: 22014: 52015: 72016: 32017: 42018: 22019: 62020: 62021: 42022: 52023: 42024: 32025: 32026 (partial year): 1
2011high 7 (2015) · low 2 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2025

2016: 12017: 12021: 22023: 62024: 12025: 2
2011high 6 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Lima Corporate S.P.A. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHXShoulder Prosthesis, Reverse Configuration11decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented8decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…8decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented8decisions
  • MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented8decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7decisions

Also: MBH (4), MEH (3), JDC (1), HSD (1), HTY (1), QHE (1).

How long do its 510(k) reviews take?

Since 2016, its 33 510(k)s took a median of 124 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 143 days; 19 of its 33 were faster than that.

Whose devices does it build on?

Its devices cite 275 predicates; 93 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 121 times; 93 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 201112cite it
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 20126cite it
  • K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 20146cite it
  • K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 20126cite it
  • K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 20126cite it
  • K141934Physica KR Knee SystemLima Corporate S.P.A. · 20155cite it

What has FDA decided for it lately?

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024
  • K234011AMF TT ConesLima Corporate S.P.A. · 2024
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
  • K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023

All 64 as Lima Corporate S.P.A. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K212800PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileMay 19, 2025Class II
  • K212800PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileMay 19, 2025Class II
  • K222807TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA…Oct 2, 2024Class II
  • K213381PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610Oct 27, 2023Class II
  • K222427PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code…Aug 29, 2023Class II
  • K222427REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RMay 30, 2023Class II

Other applicant names beginning “Lima”

FDA records each applicant name separately; these may or may not be the same firm.

Lima Intl. Corp. 8Lima-Lto S.P.A. 4