SPINE FRONTIER INDUS ACP SYSTEM— 510(k) K121060

Clearance details

Applicant

Spinefrontier, Inc.

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2012-04-06

Decision date

2012-07-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Beverly, MA, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• 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

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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-0573-2014 — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0574-2014 — Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0575-2014 — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-0576-2014 — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.Class II·Terminated·SpineFrontier, Inc.·20131120
• Z-1933-2013 — Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.Class II·Terminated·SpineFrontier, Inc.·20130621
• Z-1957-2013 — Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.Class II·Terminated·SpineFrontier, Inc.·20120509

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121060.