VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (K242296)
Description
VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) by Ortho-Design (Pty), Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242296
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (K242296) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 |
| K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 |
| K190728 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2019 |
| K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 |
| K130274 | BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TL... | Elite Surgical Supplies (Pty), Ltd. | 2013 |
| K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR | Depuy Mitek, A Johnson & Johnson Co... | 2013 |
| K070758 | STRYKER PEEK ZIP SUTURE ANCHOR | Stryker Endoscopy | 2007 |
Trace the full predicate network for K242296
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.