Who is the manufacturer of RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

Biomet Microfixation filed the 510(k) submission for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM (K130309).

What is the FDA product code for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

GXR. It is classified under 21 CFR 882.5250 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

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

Who can help prepare an FDA 510(k) submission like RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

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.

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM

Q: What are the predicate devices for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

LactoSorb® RapidFlap™ System (K003281); Aesculap CranioFix Abosorbable Device (K021408 & K040080); Synthes Rapid Resorbable Clamp (K041611).

K130309 · Biomet Microfixation · GXR · Jun 17, 2013 · Neurology

Device Facts

Record ID	K130309
Device Name	RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
Applicant	Biomet Microfixation
Product Code	GXR · Neurology
Decision Date	Jun 17, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5250
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.

Device Story

RapidFlap™ LS Cranial Fixation Flap System provides rigid fixation for craniotomy bone flaps; used in adult and pediatric populations. System consists of inner plate, outer plate, and central post; assembled by hand to capture and grip bone flap, ensuring coplanar alignment. Device made from polylactic/polyglycolic acid copolymer. Includes LactoSorb® Heat/Contouring Pen, a disposable, battery-powered tool with wire tip for cutting plates and flat tip for smoothing edges. Used by surgeons in clinical settings during craniotomy procedures to secure bone flaps, promoting healing and structural stability.

Clinical Evidence

No clinical data.

Technological Characteristics

Resorbable polylactic/polyglycolic acid copolymer construction. Mechanical fixation via two-disk system with central post. Sterile, ETO-sterilized. Includes battery-powered heat/contouring pen for manual plate modification.

Indications for Use

Indicated for rigid fixation of craniotomy in adult and pediatric populations. Contraindicated in patients with active infection, blood supply limitations, insufficient bone stock, latent infection, or decompression flaps.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

LactoSorb® RapidFlap™ System (K003281)
Aesculap CranioFix Abosorbable Device (K021408 & K040080)
Synthes Rapid Resorbable Clamp (K041611)

Related Devices

K221606 — Absorbable Cranial Flap Fixation System · Chendu Medart Medical Scientific Co., Ltd. · Nov 21, 2023
K130447 — SPEEDY FLAP SYSTEM · Jeil Medical Corporation · Dec 22, 2014
K070901 — MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM · Bioplate, Inc. · Jun 15, 2007
K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM · Neos Surgery S.L · Oct 25, 2010
K013055 — THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM · Bioplate, Inc. · Dec 7, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ ## K130309 #### 510(k) Summary #### June 11, 2013 Contact: Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 Sheryl Malmberg, Global R/A Specialist Telephone: 904-741-9465 Fax: 904-741-9425 Common of Usual Name: Cover, Burr hole Classification Name: 882.5250 - Burr hole cover Device Classification: Class II Device Product Code: GXR Device Name: RapidFlap™ LS Cranial Fixation Flap System Indications for Use / Intended Use: The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations. Contraindications: 1. Active infection: 2. Patient conditions including blood supply limitations, insufficient quantity of bone stock or latent infection; 3. DO NOT USE in patients with a decompression flap. Description: The RapidFlap™ LS Cranial Flap Fixation System is comprised of three parts, an inner plate, an outer plate and a central post. The inner plate consists of a circular disk through which the post is centrally extruded outwardly. The outer plate consists of a circular disk which a threaded hole to accept the post. The devices are assembled by hand to force the plates together capturing the bone. When applied, the plates tightly grip the bone flap, and provide rigid attachment and coplanar alignment to the surrounding bone. The RapidFlap™ LS System is made from Polylactic / polyglycolic acid copolymer. The LactoSorb® Heat /Contouring Pen is a disposable alkaline-battery powered device. Two tips are provided with the body or handle of the device. These tips can use the same handle to perform slightly different functions. The long wire tip is used to cut the LactoSorb® plates and the flat surfaced tip is used to smooth the edges of the plates. The device is supplied sterile. {1}------------------------------------------------ Sterility Information: The LactoSorb® implants are sterilized by exposure to Ethylene Oxide (ETO) Gas. Substantial Equivalence: The RapidFlap™ LS Cranial Fixation System is substantially equivalent to the LactoSorb® RapidFlap™ System (K003281), Aesculap CranioFix Abosorbable Device (K021408 & K040080) and the Synthes Rapid Resorbable Clamp (K041611). Substantial equivalence was not based on nonclinical or clinical data. The following comparison table shows that all devices are similar in design, material, sterilization and intended use. The purpose of this submission is only to include adult populations in the current indications for use, which is consistent with predicate devices shown below. | | Aesculap CranioFix Abosorbable Device (K021408 & K040080) | Synthes Rapid Resorbable Clamp (K041611) | LactoSorb® RapidFlap™ System (K003281) | RapidFlap™ LS Cranial Fixation System (subject device) | |--------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Material | Poly (L/DL- lactide) | 85:15 poly (L- lactide-co- glycolide) | Polylactic / polyglycolic acid copolymer | Polylactic / polyglycolic acid copolymer | | Material property | Resorbable | Resorbable | Resorbable | Resorbable | | Indications for Use | Covering burr holes and fixation of cranial bone flaps | Covering burr holes and fixation of cranial bone flaps in adult and pediatric populations | Pediatric craniotomy flap fixation | Rigid fixation of a craniotomy in adult and pediatric populations | | Use | Craniotomy procedures | Craniotomy procedures | Craniotomy procedures | Craniotomy procedures | | Sterility | Sterile | Sterile | Sterile | Sterile | | Components | l 1mm, 16mm & 20mm clamps | 18mm Clamp | 14mm Clamp | 14mm Clamp | | Component description | Two disks connected by a ratcheting shaft | Two disks connected by a tensioned ratcheting shaft | Inner and outer plates (each consisting of a circular disk with a threaded hole) connected by a threaded central post | Inner and outer plates (each consisting of a circular disk with a threaded hole) connected by a threaded central post | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 17, 2013 Biomet Microfixation % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133 Re: K130309 > Trade/Device Name: RapidFlap™ LS Resorbable Cranial Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: March 20, 2013 Received: March 21, 2013 Dear Ms. Scifert: 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 {3}------------------------------------------------ Page 2 - Ms. Christine Scifert 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 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. ff 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, # Victor Krauthamer -S Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K130309 Device Name: RapidFlap™ LS Resorbable Cranial Flap Fixation System Indications For Use: The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations. 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-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Victor Krautham 2013.06.14 17:46: Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) 510(k) Number K130309 Page 1 of 1