Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine

FDA 510(k) K150209 · Depuy Mitek, A Johnson and Johnson Company

Substantially Equivalent

510(k) numberK150209

Submission

Device name
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine
Applicant
Depuy Mitek, A Johnson and Johnson Company
Raynham, MA, US
Received
January 30, 2015
Decision date
October 6, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MAI

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K262357Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special Arthrex, Inc.08/07/2026SE
K253931Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional Arthrex, Inc.05/28/2026SE
K260294SF Push-in AnchorMAI · Traditional Surgical Fusion Technologies GmbH03/27/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional OSSIO , Ltd.02/24/2026SE
K251680Biosteon® ScrewMAI · Traditional Biocomposites, Ltd.02/17/2026SE
K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special Conmed Corporation10/15/2025SE
K252022OSSIOfiber® Interference ScrewMAI · Traditional OSSIO , Ltd.08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special OSSIO , Ltd.05/27/2025SE
K250544Knotilus+ Biocomposite Knotless AnchorMAI · Traditional Stryker Endoscopy05/23/2025SE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI · Traditional Stryker Endoscopy05/21/2025SE

More from Stryker Endoscopy

510(k)DeviceDecision
K140643Gryphon BR Anchor W/Proknot Technology,Gryphon PEEK Anchor W/ Proknot TechnologyMAI · Traditional 07/08/2014SE
K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLMBI · Traditional 07/07/2014SE

Questions and answers

When was Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine cleared by the FDA?

Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine (K150209) received a 510(k) decision of Substantially Equivalent on October 6, 2015, 249 days after the submission was received.

What is the product code of K150209?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.