Integra LifeSciences Corporation: FDA clearances and approvals
Integra LifeSciences Corporation has 94 FDA 510(k) clearances (first 1999, latest 2025), plus 7 PMA decisions, across 34 product codes in 7 review panels. Median 510(k) review time: 82 days. Since 2017 its median was 84 days, against 112 days for all cleared 510(k)s in the same product codes. openFDA lists 316 product recalls by a recalling firm named Integra LifeSciences Corporation. It is the industry lead sponsor of 48 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 112 |
| 2013 | 3 | 127 |
| 2014 | 8 | 120 |
| 2015 | 3 | 276 |
| 2016 | 6 | 134 |
| 2017 | 3 | 28 |
| 2018 | 7 | 91 |
| 2019 | 5 | 59 |
| 2020 | 3 | 90 |
| 2021 | 2 | 233 |
| 2022 | 2 | 44 |
| 2023 | 1 | 144 |
| 2024 | 1 | 142 |
| 2025 | 2 | 102 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Integra LifeSciences Corporation's cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 14 | 14 |
| LFL | Instrument, Ultrasonic Surgical | 13 | 13 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 10 | 10 |
| GWM | Device, Monitoring, Intracranial Pressure | 8 | 8 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 7 | 7 |
| GXQ | Dura Substitute | 6 | 6 |
| HRS | Plate, Fixation, Bone | 5 | 5 |
| JXI | Cuff, Nerve | 4 | 4 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
Plus 24 more product codes.
Review panels
- Neurology (52)
- General and Plastic Surgery (27)
- Orthopedic (15)
- Dental (3)
- Obstetrics and Gynecology (2)
- Cardiovascular (1)
- Ophthalmic (1)
Most recent Integra LifeSciences Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | 2025-10-08 | 176 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | 2025-04-09 | 28 |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | 2024-07-11 | 142 |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2023-07-11 | 144 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-08-22 | 60 |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-07-15 | 28 |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | KGN | 2021-10-08 | 262 |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | HRS | 2021-07-27 | 204 |
| K193346 | Codman Surgical Patties & Strips | HBA | 2020-11-20 | 353 |
| K201507 | Cadence Total Ankle System | HSN | 2020-06-29 | 24 |
84 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080013 | PMA | DURASEAL EXACT SPINE SEALANT SYSTEM | 2009-09-04 |
| P040034 | PMA | DURASEAL DURAL SEALANT SYSTEM | 2005-04-07 |
| P900033 | PMA | INTEGRA DERMAL REGENERATION TEMPLATE | 1996-03-01 |
| P840062 | PMA | COLLACOTE(TM) | 1985-11-08 |
| P850010 | PMA | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | 1985-11-08 |
Recalls
316 product recalls in 132 recall events; 63 initiated in the last five years. Most recent: 2025-02-06.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Integra LifeSciences Corporation is the industry lead sponsor of 48 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06629506: MicroMatrix® Flex in Tunneling Wounds (Completed, started 2024-12-12)
- NCT06453187: A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers (Enrolling by invitation, started 2024-11-18)
- NCT06276543: Bactiseal Catheter Safety Registry Study (Recruiting, started 2024-09-29)
- NCT06297187: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study (Completed, started 2024-02-23)
- NCT06034652: T-GENVIH-003 LTFU (Long Term Follow Up) Study (Completed, started 2023-09-12)
Frequently asked questions
How many FDA 510(k) clearances does Integra LifeSciences Corporation have?
Integra LifeSciences Corporation has 94 FDA 510(k) clearances (first 1999, latest 2025), plus 7 PMA decisions, across 34 product codes in 7 review panels.
How long does FDA take to clear Integra LifeSciences Corporation's 510(k)s?
The median time from FDA receipt to decision across Integra LifeSciences Corporation's cleared 510(k)s is 82 days. Since 2017: 84 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Integra LifeSciences Corporation make?
Its most frequent FDA product codes are JXG (Shunt, Central Nervous System And Components, 14); LFL (Instrument, Ultrasonic Surgical, 13); HBL (Holder, Head, Neurosurgical (Skull Clamp), 10).
Has Integra LifeSciences Corporation had device recalls?
openFDA lists 316 product recalls in 132 recall events by a recalling firm whose name matches Integra LifeSciences Corporation; the most recent began 2025-02-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 94 Integra LifeSciences Corporation clearances with predicates and recalls
- Run predicate analysis for product code JXG, Integra LifeSciences Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.