# K040381: Hatric, 6&7MM, 9&10MM, 11&12MM, 14&15MM, Models AR-13000B-07, -10, -12, -15

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 12, 2004 after 85 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The intended use for HATriCTM is that of a bone void filler or bone graft substitute in bony voids or gaps which are not intrinsic to the stability of the bony structure (i.e. extremities, pelvis, or spine). These bony voids and gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. HATriCTM may be used as a bone graft substitute for autograft or allograft when these grafts are undesirable or unavailable. When used for posterolateral fusions, the HATriCTM must be used with autograft bone material and the ratio of autograft bone material to HATriCTM must be in the range of 1.25cm3 to 2.4cm3 of autograft bone to 1cm3 of HATriCTM. HATriCTM is a bone void filler or bone graft substitute that resorbs and is replaced with bone during the healing process. HATriCTM is not intended to be a load-bearing device. Therefore rigid fixation techniques may often be recommended. In addition, when used with Arthrex Opening Osteotomy Systems' or substantially equivalent systems' plates and screws, HATriCTM is intended to be used as a bone void filler or bone graft substitute in femoral or tibial osteotomies. HATriCTM is to be used in association with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K040381
Methodology: https://510kreport.com/methodology