Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)

K-Number: K242296 · 2024-08-29

ApplicantOrtho-Design (Pty), Ltd.
Decision Date2024-08-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) is a medical device manufactured by Ortho-Design (Pty), Ltd.. It received FDA 510(k) clearance on 2024-08-29 under approval number K242296. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)?

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) is a medical device that received FDA 510(k) clearance on 2024-08-29. It is manufactured by Ortho-Design (Pty), Ltd.. The 510(k) number is K242296.

When was VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) approved by the FDA?

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) received FDA 510(k) clearance on 2024-08-29, under approval number K242296.

What company makes VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)?

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) is manufactured by Ortho-Design (Pty), Ltd..

What is the FDA product code for VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)?

The FDA product code for VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) is MBI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Ortho-Design (Pty), Ltd.

K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTi

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑