Lactosorb Suture Anchor

FDA 510(k) K954443 · Poly-Medics,Inc.

Substantially Equivalent for Some Indications

510(k) numberK954443

Submission

Device name
Lactosorb Suture Anchor
Applicant
Poly-Medics,Inc.
Warsaw, IN, US
Received
September 25, 1995
Decision date
January 31, 1996
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JDR – Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K250712Linkt Compression Staple SystemJDR · Traditional Trax Surgical05/14/2025SE
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional Medline Industries, LP04/11/2025SE
K243742Arthrex DynaNite Nitinol StaplesJDR · Traditional Arthrex, Inc.01/31/2025SE
K243658TMC Compression Implant SystemJDR · Special Treace Medical Concepts12/26/2024SE
K242415TMC Compression Implant SystemJDR · Special Treace Medical Concepts09/06/2024SE
K240212COGNiTiON™ Staple SystemJDR · Special Ortho Solutions UK , Ltd.02/23/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE

More from Novastep

510(k)DeviceDecision
K960988Lactosorb Trauma Plating SystemHRS · Traditional 04/10/1996SN
K955729Lactosorb Trauma Plating SystemHRS · Traditional 02/14/1996SN
K951658Lactosorb Pop RivetJDR · Traditional 07/25/1995SN
K934861Hard Tissue Replacement (HTR) GranularKKY · Traditional 11/04/1994SE

Questions and answers

When was Lactosorb Suture Anchor cleared by the FDA?

Lactosorb Suture Anchor (K954443) received a 510(k) decision of Substantially Equivalent for Some Indications on January 31, 1996, 128 days after the submission was received.

What is the product code of K954443?

The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.