Who is the manufacturer of OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

Osteomed LP filed the 510(k) submission for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR (K123885).

What is the FDA product code for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

PBJ. It is classified under 21 CFR 882.5330 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

OsteoMed Cranial Distraction System (K121304); KLS-Martin Molina Orbital Malar Distractor (K003883); OsteoMed External Mandibular Distraction System (K063792).

Who can help prepare an FDA 510(k) submission like OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

K123885 · Osteomed LP · PBJ · Jun 3, 2013 · Neurology

Device Facts

Record ID	K123885
Device Name	OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
Applicant	Osteomed LP
Product Code	PBJ · Neurology
Decision Date	Jun 3, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5330
Device Class	Class 2
Attributes	Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K123885 · Jun 3, 2013	OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR	Osteomed LP	Retrospective clinical case data from surgeons using similar cranial spring devices	Clinical data from 91 cases (infants 3-8.5 months) was used to evaluate distraction distance and rates to support the performance characteristics of the device.	Retrospective clinical data; Cranial distraction; Pediatric; Performance verification

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective clinical case review; Retrospective review of clinical cases; Follow-up/Duration: Six week duration	Infants ranging in age from 3 - 8.5 months; Sample Size: 91 clinical cases	Not applicable for this study	Distraction distance and distraction rate

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.

Device Story

The OsteoMed smartflex Cranial Spring Distraction System is an internal distraction osteogenesis device used in pediatric cranial surgery. It consists of stainless steel distractors anchored to the cranium via hook feet. Unlike traditional threaded-rod distractors that require manual activation by a surgeon or parent, this device applies continuous spring force to the skull bones to facilitate gradual remodeling and lengthening of prematurely closed sutures. The system includes auxiliary instruments (pliers, benders, cutters) for placement. The device is implanted during surgery and removed after bone consolidation. It provides a passive, continuous distraction mechanism compared to the active, manual distraction of predicate systems. Clinical benefits include gradual bone expansion for cranial conditions; the device is intended for single-patient use.

Clinical Evidence

No clinical trials were conducted for this submission. Substantial equivalence is supported by bench testing, including Finite Element Analysis (FEA) comparing stress on infant cranial bone against the predicate, and verification of spring geometry and force targets using optical comparators. Additionally, the manufacturer provided retrospective clinical data from literature regarding 91 cases of cranial spring distraction (performed by a physician) to verify distraction rates and safety profiles, showing a mean distraction rate of 1.39mm/day.

Technological Characteristics

Internal distractor made of medical grade stainless steel (ASTM F-138). Distraction mechanism utilizes continuous spring force rather than manual threaded rods. Anchored to cranial bone via hook feet. Provided sterile via gamma sterilization. Dimensions allow for a maximum distraction distance of 55mm.

Indications for Use

Indicated for pediatric patients, infants aged 1 month to 2 years, with syndromic craniosynostosis or congenital cranial deficiencies requiring osteotomy and gradual bone distraction for temporary stabilization and lengthening.

Regulatory Classification

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.

Predicate Devices

OsteoMed Cranial Distraction System (K121304)
KLS-Martin Molina Orbital Malar Distractor (K003883)
OsteoMed External Mandibular Distraction System (K063792)

Reference Devices

OsteoMed ReFlexion Toe Implant System (K922211)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 Image /page/0/Picture/34 description: The image shows the logo for Colson Associate. The logo consists of a circular emblem with the word "Colson" written inside it in a stylized font. To the right of the emblem, the words "A COLSON ASSOCIATE" are written in a smaller, sans-serif font. The overall design is simple and professional. {1}------------------------------------------------ #### 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is enclosed in a black, oval shape that curves above and below the text. The logo appears to be a company logo or brand name. #### 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is enclosed in a black oval shape. The oval shape is thicker on the bottom than on the top. The image is in black and white. : : · | 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 Anchored by hooks on feet (feet plates) | Distraction force applied by surgeon/parent by activating the distraction rod. | Distraction force applied by surgeon/parent by activating the distraction rod. | Distraction force applied by surgeon/parent/patient by activating the distraction rod onto the K- wires. Anchored by K-Wires through the mandibular bone. | N/A | | Maximum | 55mm* | 25mm | 35mm | 70mm | N/A | | 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 | | Distraction rate: | 0.4mm per day | 1mm per day (0.5mm twice a day) | 1mm per day (0.5mm twice a day) | 1mm per day (0.5mm twice a day) | N/A | | Materials for Implants: | Distractor: Stainless Steel (316 SS LVM) ASTM F-138 | | | Implantable K-Wires: Stainless Steel (316 SS LVM) ASTM F-138 | Titanium Alloy, CoCrMo Alloy, UHMWPE | | Bio- compatibility: | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Biocompatible | | Sterility: | Provided Sterile (Gamma) | Provided non- sterile (Steam Sterilization by end user) | Provided non-sterile (Steam Sterilization by end user) | Provided non-sterile (Steam Sterilization by end user) | Provided Sterile (Gamma) | | Techno-logical Char- acteristics: | Spring distractor | Distraction rod and tool for distraction | Distraction rod and tool for distraction | Distraction rod and tool for distraction | N/A | | Operational Principle: | Distraction osteogenesis | Distraction osteogenesis | Distraction osteogenesis | Distraction osteogenesis | N/A | 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 . · {4}------------------------------------------------ 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 Image /page/4/Picture/4 description: The image shows the logo for A Colson Associate. The logo consists of the word "Colson" in a stylized font inside of a black circle. To the right of the circle, the words "A Colson Associate" are written in a smaller, sans-serif font. {5}------------------------------------------------ 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

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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