Zimmer Biomet: FDA 510(k) clearances across all its applicant names

FDA lists 1,374 510(k) clearances, 6 PMA and 0 De Novo decisions across the 30 applicant names Caduvo groups under Zimmer Biomet, first 1976, latest 2026. Median 510(k) review time across these names: 87 days. Since 2017 the median was 94 days, against 115 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 30 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.

Top product codes

Plus 139 more product codes.

Review panels

• Orthopedic (1,246)
• Neurology (28)
• Dental (24)
• General and Plastic Surgery (24)
• General Hospital (20)
• Physical Medicine (14)
• Clinical Chemistry (3)
• Cardiovascular (3)
• Radiology (3)
• Ear, Nose and Throat (2)
• Gastroenterology and Urology (2)
• Obstetrics and Gynecology (1)
• Ophthalmic (1)

Most recent Zimmer Biomet 510(k) clearances

1,364 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2,635 product recalls in 612 recall events under these names; 139 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Zimmer acquired Centerpulse (formerly Sulzer Orthopedics, 2003) and Biomet (2015); also Medtech SA (ROSA robot, 2016) and Paragon 28 (2025). Includes filings made before each acquisition. Left out: spine and dental (Zimmer Spine, Biomet Spine/EBI, Zimmer Dental, Biomet 3i, LDR, Lanx) — spun off as ZimVie in March 2022. ZIMMER and BIOMET names still contain some pre-2022 spine/dental filings that cannot be split out. Zimmer MedizinSysteme (German physiotherapy maker) is an unrelated company. Also left out: joint ventures (Biomet Merck, Biomet USSC), Hall Surgical (sold to Linvatec/CONMED), Zimmer Aspen Labs and Zimmer Patient Care (businesses later sold).

Sources

• https://en.wikipedia.org/wiki/Zimmer_Biomet
• https://www.sec.gov/Archives/edgar/data/1136869/000119312522061356/d650132dex991.htm

Frequently asked questions

How many FDA 510(k) clearances are listed across Zimmer Biomet's applicant names?

FDA lists 1,374 510(k) clearances, 6 PMA and 0 De Novo decisions across the 30 applicant names Caduvo groups under Zimmer Biomet, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Zimmer Biomet file under?

The names with the most 510(k) clearances in this group are Biomet, Inc. (445); Zimmer, Inc. (422); Biomet Manufacturing Corp (128); Intermedics Orthopedics (108); Paragon 28, Inc. (60). The full list of 30 names is on this page.

How long does FDA take to clear Zimmer Biomet 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 87 days. Since 2017 the median was 94 days, against 115 days for all cleared 510(k)s in the same product codes.

Does the Zimmer Biomet count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 1,374 Zimmer Biomet clearances with predicates and recalls
• Run predicate analysis for product code JWH, Zimmer Biomet's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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