# K963700: Metagen High Tibial Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Metagen, LLC
- Decided: Feb 12, 1997 after 149 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NexGen Osteotomy System (Zimmer): named in the summary without a submission number
- (no number) Natural Knee Family High Tibial Osteotomy System (Intermedics Orthopedics): named in the summary without a submission number
- (no number) High Tibial Osteotomy System (Richards): named in the summary without a submission number
- (no number) L-buttress, T-buttress and T-plates (Synthes): named in the summary without a submission number
- (no number) ECT Internal Fracture Fixation System (Zimmer): named in the summary without a submission number
- (no number) Improved Geibel Blade Plates (Link America Inc.): named in the summary without a submission number
- (no number) Osteo Auto-Compression Plating System (Smith & Nephew Richards): named in the summary without a submission number
- (no number) May Anatomical Bone Plates (Waldemar Link): named in the summary without a submission number

## Most influential descendants
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K063709: TS-Bone Hip Tool (2007), 1 descendant of its own
- K040850: Tsy Shoulder Plate Implant (2004), 1 descendant of its own
- K072175: Titanium Hip Tool Locking Plate (2007), 0 descendants of its own
- K063033: Modification to Titanium Shoulder Plate Implant (2006), 0 descendants of its own

## Indications for use
The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies. Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.

Source page: https://510kreport.com/device/K963700
Methodology: https://510kreport.com/methodology