Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for bone distraction and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes.
This device is designed to treat cranial conditions by gradually lengthening cranial bones, which is a therapeutic intervention.

Diagnostic

No

This device is a distraction osteogenesis system intended for the physical treatment (lengthening and stabilization) of cranial bones, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components made of medical-grade stainless steel (distractors, foot plates, instruments) and describes mechanical actions (applying continuous force, gradual lengthening). There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the treatment of cranial conditions by providing temporary stabilization and gradual lengthening of cranial bones. This is a therapeutic intervention performed in vivo (within the body).
Device Description: The description details a system of distractors anchored to the cranium to apply force to bone segments. This is a mechanical device used for surgical procedures.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to physically manipulate bone.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation.

The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Product codes (comma separated list FDA assigned to the subject device)

PBJ

Device Description

The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation.

The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors.

The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cranium

Indicated Patient Age Range

Pediatrics; Sub-population - Infant greater than 1 month to 2 years of age

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)

The OsteoMed smartflex Cranial Spring Distraction System was compared to the distraction rates and verified forces of the OsteoMed Cranial Distraction System. Verification testing consisted of the following tests;

Finite Element Analysis of Forces Applied to Adjacent bone simulating infant skull properties for the Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created. The results show that both devices exerted a stress on the cranial bone below the yield strength of infant cranial bone. The stress on the cranial bone for the Cranial Spring Distractor was 80% below the stress on the cranial bone of the Cranial Distractor (predicate).
Distraction distance was evaluated graphically using clinical data obtained by surgeons with cranial spring devices similar to our device. The data included 91 clinical cases performed on infants ranging in age from 3 - 8.5 months with cranial springs manufactured by a physician in cranial distraction, 31 cases reached 55mm of distraction and 60 cases went safely beyond 55mm with only one clinical complication, a skin infection and 3 spring related complications (repositioning of the springs). The maximum possible distraction distance of the OsteoMed Cranial Spring Distractor is 55mm because that is the maximum length at free state that does not compromise patient safety.
Distraction rate was obtained from the clinical data and distraction rates compared to the predicate. The distraction rate on average with a six week duration was 1.39mm per day.
The OsteoMed smartflex Cranial Spring Device design was verified to prove the spring geometry and force targets were met as described in the literature. Spring geometry was verified using an optical comparator and the implants were compressed between the footplates to simulate initial force at implantation, where the force was measured.

Clinical Testing is not required to support substantial equivalence.

In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121304, K003883, K063792

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K922211

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in a bold, sans-serif font. The word is enclosed in a black oval shape. The oval shape has a white outline, which makes the word stand out. The logo appears to be for a company called Osteomed.

K123885

510(k) Summary

JUN 0 3 2013

Submitter Information:

OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601

Contact Person:

Mrs. Piedad Peña

Date Prepared:

May 15, 2013

Device Information:

Common Name: Classification Name:

Proprietary/Trade Name: OsteoMed smartflex Cranial Spring Distraction System Cranial Spring Distractor

o Requlation Number: 21 CFR 882,5330

o Regulation Name: Preformed nonalterable cranioplasty plate
o Product Code: PBJ

Device Class: II

Predicate Devices:

OsteoMed Cranial Distraction System, K121304

o Classification Name: Regulation Number: 21 CFR 882.5330
· Regulation Name: Preformed nonalterable cranioplasty plate
o Product Code: PBJ

Device Class: II

KLS - Martin, Molina Orbital Malar Distractor, K003883

o Classification Name: Regulation Number: 21 CFR 872.4760
o Regulation Name: Bone Plate
o Product Code: JEY
Device Class: II

OsteoMed External Mandibular Distraction System, K063792

o Classification Name: Regulation Number: 872.4760
o Regulation Name: Bone Plate
o Product Code: MQN

Device Class: 11

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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Device Description:

The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation.

The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors.

The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.

Indications For Use/Intended Use:

The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Intended use is equivalent to the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices.

Target Population:

Pediatrics; Sub-population - Infant greater than 1 month to 2 years of age

Technological Characteristics:

The OsteoMed and KLS predicate devices are internal distractors for bone elongation, which distracts manually via a threaded rod and are anchored using bone screws. The KLS distractor predicate has hook feet which anchor to the cranial bone edge and uses bone screws to anchor to the cranial bone. The OsteoMed smartflex Cranial Spring Distractor is also an internal distractor for bone elongation as the predicate devices, but it distracts via continuous spring force and is anchored by hook feet to the cranial bone edge.

Material used for the OsteoMed smartflex Cranial Spring Distractor is medical grade stainless steel. The material used for the OsteoMed External Mandibular Distraction System (K063792) implantable K-wires, which are implanted during distraction, are medical grade stainless steel. The stainless steel material used in the OsteoMed smartflex Cranial Spring Distractor and the OsteoMed Implantable K-wire is biocompatible.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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Performance / Clinical Data:

The OsteoMed smartflex Cranial Spring Distraction System was compared to the distraction rates and verified forces of the OsteoMed Cranial Distraction System. Verification testing consisted of the following tests;

. Finite Element Analysis of Forces Applied to Adjacent bone simulating infant skull properties for the Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created. The results show that both devices exerted a stress on the cranial bone below the vield strength of infant cranial bone. The stress on the cranial bone for the Cranial Spring Distractor was 80% below the stress on the cranial bone of the Cranial Distractor (predicate).
Distraction distance was evaluated graphically using clinical data obtained by . surgeons with cranial spring devices similar to our device. The data included 91 clinical cases performed on infants ranging in age from 3 - 8.5 months with cranial springs manufactured by a physician in cranial distraction, 31 cases reached 55mm of distraction and 60 cases went safely beyond 55mm with only one clinical complication, a skin infection and 3 spring related complications (repositioning of the springs). The maximum possible distraction distance of the OsteoMed Cranial Spring Distractor is 55mm because that is the maximum length at free state that does not compromise patient safety.
Distraction rate was obtained from the clinical data and distraction rates . compared to the predicate. The distraction rate on average with a six week duration was 1.39mm per day.
The OsteoMed smartflex Cranial Spring Device design was verified to prove the . spring geometry and force targets were met as described in the literature. Spring geometry was verified using an optical comparator and the implants were compressed between the footplates to simulate initial force at implantation, where the force was measured.

The indications for use of the OsteoMed smartflex Cranial Spring Distraction System are the same as the OsteoMed Cranial Distraction System (K121304) and KLS-Martin Molina Distraction System (K003883) predicate devices.

Clinical Testing is not required to support substantial equivalence.

In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices.

Substantial Equivalence:

Substantial equivalence for this device is based on similarities in intended use, indications for use, function, performance, and operational principle to the predicate devices, OsteoMed Cranial Distraction System (K121304) and KLS-Martin Molina Distraction System (K003883), based on their promotional materials, labeling and clearance letters. The basis for substantial equivalence for this device is also on similarities in materials with the OsteoMed External Mandibular Distraction System (K063792) implantable Stainless Steel K-wires base on their promotional materials, labeling and clearance letters. The system is provided sterile based on the predicate device (K922211) Sterilization Testing.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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:

·

| System/ MFG
Device | OsteoMed
Smartflex
Cranial Spring
Distractor | OsteoMed
Cranial
Distraction
System | KLS-Martin Molina
Orbital Malar
Distractor | OsteoMed External
Mandibular Distraction
System | OsteoMed
ReFlexion Toe
Implant System |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) | (New) | K121304 | K003883 | K063792 | K922211 |
| Purpose | | (Predicate) | (Predicate) | (Predicate - Material
implant) | (Predicate - Gamma
Sterilization) |
| Product Code/
Classification | PBJ
21CFR882.533
0 | PBJ
21CFR882.5330 | JEY, 21CFR
872.4760 | JEY 21CFR
872.4760 | LZJ, Unclassifed |
| Intended use: | Cranial
conditions | Cranial conditions | Cranial and Midface
Conditions | External distraction of
Mandible Conditions | reconstruction of the
1st MTP, resulting
from osteoarthritis,
rheumatoid arthritis,
traumatic arthritis or
revision of previous
arthroplasty |
| Indications for
use: | Intended for
use in the
treatment of
cranial
conditions such
as syndromic
craniosynostosi
s and
congenital
deficiencies in
which
osteotomies
and gradual
bone distraction
are indicated.
This device is
intended to
provide
temporary
stabilization
and gradual
lengthening of
the cranial
bones. This
device is
intended to be
removed after
consolidation. | Intended for use
in the treatment of
cranial conditions
such as
syndromic
craniosynostosis
and congenital
deficiencies in
which
osteotomies and
gradual bone
distraction are
indicated. This
device is intended
to provide
temporary
stabilization and
gradual
lengthening of the
cranial bones.
This device is
intended to be
removed after
consolidation. | KLS-Martin Molina
Orbital Malar Distractor
is intended for use in
the treatment of cranial
and midface conditions
such as syndromic
craniosynostosis and
congenital midface
deficiencies in which
osteotomies and
gradual bone
distraction are
indicated. This device
is intended to provide
temporary stabilization
and gradual
lengthening of the
cranial and midface
bones. | The OsteoMed External
Mandibular Distraction
System, which is a family
of external distraction
osteogenesis devices for
bone elongation for the
correction of congenital
deficiencies, mandibular
hypoplasia or post
traumatic defects of the
mandible that require
gradual distraction. The
OsteoMed External
Mandibular Distraction
System is intended for
use in either adults or
pediatric patients.
The OsteoMed External
Mandibular Distraction
System is intended for
single patient use only. | three-piece implant
system designed for
the reconstruction of
the 1st MTP,
resulting from
osteoarthritis,
rheumatoid arthritis,
traumatic arthritis or
revision of previous
arthroplasty |
| Target
population: | Pediatrics | Pediatrics | Pediatrics | Pediatrics and Adults | Adults |
| Anatomical
sites: | Cranium | Cranium | Cranium and Midface | Mandible | 1st MPJ (toe) |
| Function: | Distraction of
cranial bones | Distraction of
cranial bones | Distraction of cranial
and midface bones. | Distraction of mandibular
bones | Reconstruction of
the 1st MPJ |
| Design: | Distraction via
spring forces
and

OsteoMed OsteoMed OsteoMed OsteoMed
(388 Addison, Tepahone Addison, Tepahone (1800)
(872) 677-4600 Addison, Texas (2001)
(872) 677-4600 Addison, 1989 (2007) 1589 (200

:

colson a culson associate

. ·

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Due to the similarity of intended use, indications for use, function, materials, performance, and operational principle to the predicate devices, OsteoMed believes that the OsteoMed smartflex Cranial Spring Distraction System does not raise any new safety or effectiveness issues.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is aligned to the left. There is a logo to the left of the text. The logo is a stylized image of three lines.

June 3rd, 2013

Public Health Service

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

OsteoMed % Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001

Re: K123885

Trade/Device Name: OsteoMed smartflex Cranial Spring Distraction System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: April 23, 2013 Received: April 24, 2013

Dear Ms. Peña:

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 -Gosmetic-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 [II (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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

6

Page 2 - Ms. Piedad Peña

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer. Ph.D. Acting Director Director of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known): K123885

Device Name: OsteoMed smartflex Cranial Spring Distraction System

Indications For Use:

The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation.

The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Target Population: Pediatrics; Sub-population - Infant greater than 1 month to 2 years of age

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE.BELOW.THIS.LINE_CONT.INUE_ON.ANOTHER.PAGE.IF NEEDED)-

Concurrence of CDRH. Office of Device Evaluation (ODE)

Joyce M. Whang -

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123885