Lima Corporate S.P.A.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Lima Corporate S.P.A.” (first 2011, latest 2026), across 15 product codes in 1 review panel. Median 510(k) review time under this name: 121 days. Since 2017 the median was 128 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Enovis (DJO), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 288 |
| 2013 | 2 | 70 |
| 2014 | 5 | 77 |
| 2015 | 7 | 150 |
| 2016 | 3 | 100 |
| 2017 | 4 | 274 |
| 2018 | 2 | 144 |
| 2019 | 6 | 140 |
| 2020 | 6 | 140 |
| 2021 | 4 | 68 |
| 2022 | 5 | 62 |
| 2023 | 4 | 144 |
| 2024 | 3 | 30 |
| 2025 | 3 | 86 |
| 2026 | 1 | 177 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lima Corporate S.P.A. took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 11 | 11 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 8 | 8 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 8 | 8 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 8 | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 | 7 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 4 | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (64)
Most recent Lima Corporate S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | PHX | 2026-01-22 | 177 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | LPH | 2025-08-29 | 86 |
| K243826 | SMR Reverse HP Shoulder System | PHX | 2025-07-03 | 203 |
| K250980 | Physica System (Physica CR Porous Femoral components) | MBH | 2025-05-22 | 52 |
| K243615 | Physica Porous Femoral Components | MBH | 2024-12-18 | 26 |
| K234011 | AMF TT Cones | JWH | 2024-01-18 | 30 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | MBF | 2024-01-11 | 52 |
| K231099 | SMR Hybrid Glenoid System | MBF | 2023-12-21 | 247 |
| K231925 | MINIMA S System | LZO | 2023-07-11 | 11 |
| K221758 | SMR Stemless Anatomic | PKC | 2023-03-17 | 274 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lima Corporate S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lima Intl. Corp. (8 510(k)s)
- Lima-Lto, Inc. (2 510(k)s)
- Lima-Lto S.P.A. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lima Corporate S.P.A.?
FDA lists 64 510(k) clearances under the applicant name “Lima Corporate S.P.A.” (first 2011, latest 2026), across 15 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lima Corporate S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lima Corporate S.P.A. is 121 days. Since 2017: 128 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lima Corporate S.P.A.?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 11); KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 8); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 8).
Next steps
- See all 64 Lima Corporate S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code PHX, Lima Corporate S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.