Chrysalis Intelligence · Sponsors · Bioventus, LLC

Bioventus, LLC

Durham, NC, US · 5 510(k) clearances · 15 PMAs · 1 recalls

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Total clearances
5
2020-06-18 → 2025-07-16
Last 12 months
0
Product codes
3
Most recent
2025-07-16
Name variants in FDA filings: Bioventus, LLC / Bioventus
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Class II Neurology 2 2025-07-16
MQV Filler, Bone Void, Calcium Compound Class II Orthopedic 2 2023-12-05
FMF — — — 1 2024-06-25
Class III

PMA approvals (15)

Total PMA records
15
Originals + supplements
Distinct product codes
2
First decision
2020-10-08
Most recent
2026-03-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-03-06 P900009-S050 SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A 30-Day Notice LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2025-12-23 P170007-S015 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2023-12-21 P900009-S049 EXOGEN® Ultrasound Bone Healing System Normal 180 Day Track No User Fee LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2022-10-14 P170007-S014 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-03-03 P170007-S013 Durolane 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-03-02 P170007-S012 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-01-25 P170007-S011 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2022-01-07 P900009-S048 Exogen 30-Day Notice LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2021-12-22 P170007-S010 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-08-31 P900009-S047 EXOGEN Ultrasound Bone Healing System Normal 180 Day Track LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2021-05-25 P170007-S009 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2021-04-14 P900009-S046 EXOGEN Ultrasound Bone Healing System 30-Day Notice LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2020-11-29 P170007-S007 DUROLANE Normal 180 Day Track MOZ Acid, Hyaluronic, Intraarticular Unknown
2020-10-21 P170007-S008 DUROLANE 30-Day Notice MOZ Acid, Hyaluronic, Intraarticular Unknown
2020-10-08 P170007-S006 DUROLANE Real-Time Process MOZ Acid, Hyaluronic, Intraarticular Unknown
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2020-12-17
DateSeverityStatusRecall # ProductCodeReason
2020-12-17 Class II Terminated Z-0810-2021 EXOGEN Ultrasound Coupling Gel — Product may contain white particulates that are microbial in nature.
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-07-16 K243782 StimTrial Neuromodulation System GZF Class II Neurology
2025-07-03 K243678 TalisMann Neuromodulation System GZF Class II Neurology
2024-06-25 K233368 Allograft Delivery Device (OFAC-C) FMF — —
2023-12-05 K233490 SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty MQV Class II Orthopedic
2020-06-18 K193513 SIGNAFUSE Bioactive Bone Graft MQV Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence