← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K072546 # SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM (K072546) _Depuy Spine, Inc. · KWQ · Oct 5, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072546 ## Device Facts - **Applicant:** Depuy Spine, Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Oct 5, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications. ## Device Story System consists of titanium alloy plates and screws for anterior cervical intervertebral body fixation; used by surgeons in clinical settings to provide stability following cervical fusion; device implanted to address symptomatic cervical spondylosis, trauma, tumors, or degenerative disc disease; provides mechanical stabilization of spinal segments C2-T1. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Manufactured from ASTM F-136 implant grade titanium alloy. System comprises plates and screws for spinal fixation. Manual surgical instruments included. ## Regulatory Identification A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions. ## Predicate Devices - SWIFT™ Anterior Cervical Plate System ([K040655](/device/K040655.md)) - EAGLE™ Plus Anterior Cervical Plate System ([K070994](/device/K070994.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## IX. 510(k) Summary | SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Frank S. Jurczak | | DATE PREPARED: | September 5, 2007 | | CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis | | PROPRIETARY NAME: | SWIFT™ Plus Anterior Cervical Plate System | | PREDICATE DEVICES: | SWIFT™ Anterior Cervical Plate System
(K040655) | | | EAGLE™ Plus Anterior Cervical Plate System
(K070994) | | DEVICE DESCRIPTION: | The SWIFT Plus Anterior Cervical Plate System
consists of an assortment of plates and screws. | | | The SWIFT Plus Anterior Cervical Plate System also
contains Class 1 manual surgical instruments and
cases that are considered exempt from premarket
notification. | | INTENDED USE: | The indications for use for the modified devices
described in this submission are the same as those
for the previously cleared SWIFT Anterior Cervical
Plate System. The indications are as follows: | | | The SWIFT™ Plus Anterior Cervical Plate System is
intended for anterior cervical intervertebral body
fixation. This system is indicated for patients in which
stability is desired following anterior cervical fusion for
the indications listed below. The intended levels for
treatment range from C2 to T1. | | | Indications include symptomatic cervical spondylosis,
trauma, fracture, post-traumatic kyphosis or lordosis,
tumor, degenerative disc disease (defined as | {1}------------------------------------------------ pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications. - MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy. | PERFORMANCE | |-------------| | DATA: | Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072546](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072546) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com