Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and testing, with no mention of AI/ML terms or functionalities.

Therapeutic

No.
The device is described as an implantable system for temporary stabilization of the spine, which is a structural support function, not a therapeutic treatment.

Diagnostic

No

This device is an Anterior Cervical Plate System, which is used for temporary stabilization of the spine during fusion procedures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is composed of plates and screws, which are physical hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Asfora Anterior Cervical Plate System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device is for providing temporary stabilization to the anterior spine during cervical spine fusions. This is a surgical procedure performed directly on the patient's body.
Device Description: The description details a physical implantable device (plates and screws) used in surgery.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Asfora system does not involve the analysis of such specimens.
Performance Studies: The performance studies described are mechanical tests on the device itself, not studies involving biological samples or diagnostic accuracy.

Therefore, the Asfora Anterior Cervical Plate System is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion

Product codes

KWQ

Device Description

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior spine, cervical spine (C2-T1)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff Spinal System 510(k)s and safety testing using ASTM F 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included static and dynamic compression bending, and static torsion.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030866, K022344

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.

Summary

0

K122497

510(k) Summary

OCT 15 2012

| Submitter: | Medical Designs, LLC
6709 S. Minnesota Ave, Suite 204
Sioux Falls, South Dakota 57108-2593 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristi Vondra, Vice President of Operations
Tel: (605) 275-1032
FAX: (605) 335-3734 |
| Date Prepared: | August 15, 2012 |
| Trade Name: | Asfora Anterior Cervical Plate System |
| Classification: | Class II
Spinal intervertebral body fixation orthosis
21 CFR §888.3060 |
| Product Code: | KWQ |
| Predicate
Device(s): | The subject device is substantially equivalent to the following devices:
• Synthes Anterior CSLP System (Synthes, K030866)
• Trinica Select™ Anterior Cervical Plate System (Centerpulse
Spine-Tech, K022344), currently marketed by Zimmer Spine |
| Device
Description: | The Asfora Anterior Cervical Plate System is composed of plates of
varying lengths to accommodate surgical procedures from one to four
levels. The plates are designed for application to the anterior aspect of
the cervical spine and have manual locking mechanisms to reduce the
potential for screws to back out of the vertebral body. The screws are
provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from
14mm to 16mm |
| Intended Use: | The Asfora Anterior Cervical Plate System is intended to provide
temporary stabilization to the anterior spine during the development of
cervical spine fusions (C2-T1) for the following indications:
degenerative disc disease (DDD) (defined as neck pain of discogenic
origin with degeneration of the disc confirmed by history and
radiographic studies), spondylolisthesis, trauma (i.e., fracture or
dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous
fusion |

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1

Substantial Equivalence:

Similarities to Predicate Devices
Parameter	Medical Designs
Cervical Plate
System
(Subject Device)	Synthes Anterior
CSLP System
(K030866)	Centerpulse
Spine-Tech
Trinica Select™
Anterior Cervical
Plate System
(K022344)
Intended Use	The cervical plate
system is intended
for use in anterior
interbody screw
fixation of the
cervical spine.	same	same
Principle of
Operation	Fixation is
achieved by
inserting bone
screws through
openings in the
plate into the
vertebral bodies of
the cervical spine.	same	same
System
Components	Plates (1-4
levels)
Locking
Screws
Screw locking
mechanisms	same	same
Material	Titanium
(Ti-6Al-4V alloy
per ASTM F136)	same
(Implant grade
commercially pure
titanium)	same
(Ti-6Al-4V alloy
per ASTM F136)
Sterility	Non-Sterile.
Hospital steam
sterilization
recommended	same	same
Differences from Predicate Devices
Parameter	Medical Designs
Cervical Plate
System
(Subject Device)	Synthes Anterior
CSLP System
(K030866)	Centerpulse
Spine-Tech
Trinica SelectTM
Anterior Cervical
Plate System
(K022344)
Indications for
Use Statement	The Asfora The
Asfora Anterior
Cervical Plate
System is intended
to provide
temporary
stabilization to the
anterior spine
during the
development of
cervical spine
fusions (C2-T1)
for the following
indications:
degenerative disc
disease (DDD)
(defined as neck
pain of discogenic
origin with
degeneration of
the disc confirmed
by history and
radiographic
studies),
spondylolisthesis,
trauma (i.e.,
fracture or
dislocation),
spinal stenosis,
deformities or
curvatures (i.e.,
scoliosis,
kyphosis, and/or
lordosis), tumor,
pseudoarthrosis,
and failed
previous fusion	The Synthes Anterior
CSLP System is
intended for anterior
screw fixation to the
cervical spine (C2-
C7) for the following
indications:

Spondylolisthesis
Fracture
Spinal stenosis
Tumor
Degenerative disc
disease (as defined by
neck pain of
discogenic origin
with degeneration of
the disc confirmed by
patient history and
radiographic studies). | The
Trinica/Trinica
Select Anterior
Cervical Plate
System is intended
for anterior
interbody screw
fixation of the
surgical spine at
levels C2-T1. The
system is
indicated for use
in the temporary
stabilization of the
anterior spine
during the
development of
cervical spine
fusions in patients
with degenerative
disc disease (as
defined by neck
pain of discogenic
origin of the disc
confirmed by
patient history and
radiographic
studies), trauma
(including
fractures), tumors,
deformity (defines
as kyphosis,
lordosis, or
scoliosis),
pseudoarthrosis,
and/or failed
previous fusions. |
| Plate Lengths | 23-93 mm | 23-109 mm | 22-92mm |
| Locking Screw
Size | • Ø 4.0 mm
14-16 mm | • Ø 4.0-4.5mm
12-20 mm length | • Ø 4.2-4.6 mm
12-20 mm length |
| Screw Locking
Mechanisms | Locking rings are
preassembled onto
the plate and
include anti-
rotational locking
features and safety
locking tabs that
engage to prevent
the screws from
backing out. | The system includes
expansionhead
screws and locking
screws which lock to
the plate. | Locking caps are
preassembled onto
the plate and are
designed with tabs
that prevent bone
screws from
backing out. |
| Additional Screw
Types | Temporary
Fixation : Ø 3.5
mm, 14 mm
Rescue: Ø 5.0
mm, 14 mm and
Ø 5.0 mm, 16 mm | none | Threaded
temporary fixation
pins, sizes not
available |

2

.

K122417
Page 3 of Y

3

Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff Spinal System 510(k)s and safety testing using ASTM F 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included static and dynamic compression bending, and static torsion.

Medical Designs, LLC considers the Asfora Anterior Cervical Plate System to be equivalent to the predicate devices listed above. This Conclusion: conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

Functional and

Safety Testing:

K 122497 4 of 1

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
15
2012

Medical Designs, LLC % Ms. Kristi Vondra Vice President of Operations . 6709 South Minnesota Avenue, Suite 204 Sioux Falls, South Dakota 57108-2593

Re: K122497

Trade/Device Name: Asfora Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 15, 2012 Received: August 16, 2012

Dear Ms. Vondra:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

5

Page 2 - Ms. Kristi Vondra

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

4.0 Indications for Use Statement

Device Name: Asfora Anterior Cervical Plate System

The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D

AND/OR

.
.
.

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cal-R

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122497

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