SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM— 510(k) K123164

Clearance details

Applicant

Spinefrontier, Inc.

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2012-10-09

Decision date

2013-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beverly, MA, US

• K162066 — Reliance Spinal Screw System2016-12-02
• K162801 — CastleLoc Spinal Fixation System2016-11-03
• K162143 — FixxSure® X-Link2016-09-23
• K161151 — Spinal fixation system2016-09-21
• K162189 — ANAX 5.5 Spinal System2016-08-30

• K193106 — SpineFrontier Lumbar Interbody Fusion Device System2020-06-19
• K172484 — A-CIFT SoloFuse2018-05-08
• K151198 — A-CIFT SoloFuse2015-07-17
• K142504 — SpineFrontier Lumbar Interbody Fusion Device System2015-05-13
• K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System2015-04-24

Injury

978

Malfunction

793

Total

1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1479-2015 — SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.Class II·Terminated·SpineFrontier, Inc.·20150305
• Z-0553-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0554-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0555-2014 — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0544-2014 — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.Class II·Terminated·SpineFrontier, Inc.·20131018
• Z-0624-2014 — PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.Class II·Terminated·SpineFrontier, Inc.·20130911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123164.