Bioventus, LLC: FDA filings under this applicant name

FDA lists 7 510(k) clearances under the applicant name “Bioventus, LLC” (first 2017, latest 2026), plus 2 PMA decisions, across 5 product codes in 3 review panels. Median 510(k) review time under this name: 218 days. Since 2017 the median was 218 days, against 128 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Bioventus, LLC took a median 218 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.

Top product codes

Review panels

• Orthopedic (5)
• Neurology (3)
• General Hospital (1)

Most recent Bioventus, LLC 510(k) clearances

PMA and De Novo decisions

Recalls

2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-12-17.

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.

Device clinical trials

An industry sponsor named Bioventus, LLC is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05644639: Study of StimRouter for Chronic Knee OA Pain (Completed, started 2022-10-18)
• NCT03382483: Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk (Completed, started 2017-10-16)
• NCT02610504: Prospective Single Center Open Label Study of Shoulder OA Pain (Completed, started 2015-04-08)
• NCT02110238: Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA (Completed, started 2014-03)
• NCT01295580: Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis Pain (Completed, started 2011-01)

SEC filings

Bioventus Inc. (BVS): EDGAR filings, CIK 1665988. An SEC registrant with the same name, matched by name only.

Frequently asked questions

How many FDA 510(k) clearances are listed under Bioventus, LLC?

FDA lists 7 510(k) clearances under the applicant name “Bioventus, LLC” (first 2017, latest 2026), plus 2 PMA decisions, across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Bioventus, LLC?

The median time from FDA receipt to decision across 510(k)s cleared under the name Bioventus, LLC is 218 days. Since 2017: 218 days, versus 128 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Bioventus, LLC?

The most frequent FDA product codes under this applicant name are GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief), 3); MQV (Filler, Bone Void, Calcium Compound, 3); FMF (Syringe, Piston, 1).

Next steps

• See all 7 Bioventus, LLC clearances with predicates and recalls
• Run predicate analysis for product code GZF, Bioventus, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

All FDA device companies · FDA product code lookup