Who is the manufacturer of Absorbable Cranial Flap Fixation System?

Chendu Medart Medical Scientific Co., Ltd. filed the 510(k) submission for Absorbable Cranial Flap Fixation System (K221606).

What is the FDA product code for Absorbable 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 Absorbable Cranial Flap Fixation System?

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

What are the predicate devices for Absorbable Cranial Flap Fixation System?

RapidFlap LS Cranial Fixation Flap System (K130309).

Who can help prepare an FDA 510(k) submission like Absorbable 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.

Absorbable Cranial Flap Fixation System

K221606 · Chendu Medart Medical Scientific Co., Ltd. · GXR · Nov 21, 2023 · Neurology

Device Facts

Record ID	K221606
Device Name	Absorbable Cranial Flap Fixation System
Applicant	Chendu Medart Medical Scientific Co., Ltd.
Product Code	GXR · Neurology
Decision Date	Nov 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.

Device Story

Absorbable Cranial Flap Fixation System provides rigid fixation and coplanar alignment of cranial bone flaps post-craniotomy. Device consists of lower disc, upper disc, connecting rod, and rotating lock; upper disc moves axially along rod via rotation to grip bone flap. Manufactured from poly-L-lactic acid; supplied sterile for single use. Includes battery-powered Heat/Contouring Pen accessory for trimming excess rod. Used in clinical/surgical settings by neurosurgeons. Output is mechanical stabilization of bone flap; facilitates healing by maintaining alignment. Benefits include rigid fixation using resorbable materials, eliminating need for permanent metal implants.

Clinical Evidence

No clinical data. Evidence is based on bench testing and biocompatibility evaluation. Bench testing compared tripping force, compression force, and torque force against the predicate, showing no statistical difference. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization, intracutaneous reactivity, acute/subchronic systemic toxicity, pyrogenicity, bone implantation, degradation, and genotoxicity (ISO 10993-3, 6, 10, 11, 13). All tests passed.

Technological Characteristics

Material: Poly-L-lactic acid (resorbable). Components: Lower disc, upper disc, connecting rod, rotating lock. Accessory: Lithium battery-powered Heat/Contouring Pen. Sterilization: Ethylene Oxide (EO). Mechanical principle: Axial compression via threaded rotation. Performance metrics: Tripping force, compression force, torque force. No software or electronic algorithms.

Indications for Use

Indicated for fixation of cranial bone flaps following craniotomy in patients undergoing such procedures.

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

RapidFlap LS Cranial Fixation Flap System (K130309)

Related Devices

K130309 — RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM · Biomet Microfixation · Jun 17, 2013
K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM · Neos Surgery S.L · Oct 25, 2010
K071138 — CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM · Prosurg, Inc. · Aug 15, 2007
K992905 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM · Codman & Shurtleff, Inc. · Aug 1, 2000
K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System · Inion OY · Nov 7, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date November 21, 2023. The text is written in a clear, sans-serif font. The date is presented in a standard format, with the month, day, and year clearly indicated. The text is horizontally aligned and evenly spaced. Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. Chendu MedArt Medical Scientific Co., Ltd. % Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China Re: K221606 Trade/Device Name: Absorbable Cranial Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: October 20, 2023 Received: October 23, 2023 Dear Joyce Yang: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/8 description: The image shows the name "Adam D. Pierce -S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce -S" is present. Below this, the date "2023.11.21" and time "09:27:14-05'00'" are listed. Adam D. Pierce. Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices {2}------------------------------------------------ OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221606 Device Name Absorbable Cranial Flap Fixation System Indications for Use (Describe) The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary # Date prepared: November 15, 2023 # 1. Submitter | 1. Submitter | | |--------------------------|---------------------------------------------------------------------------------------------------| | Applicant Name | Chengdu MedArt Medical Scientific Co., Ltd. | | Address | No.102, Tianying Road, Chengdu High-tech Industrial Development Zone, 611731 Sichuan, China | | Contact person | Huaping Ran | | Phone | 086-28-87958626 | | E-mail | yangm@biomedart.cn | | 2. Device Identification | | | Trade Name | Absorbable Cranial Flap Fixation System | | Regulation Number | 21 CFR § 882.5250 | | Device Class | II | | Regulation Description | Burr hole cover | | Product Code | GXR | | 3. Predicate Device | | | Trade Name | RapidFlap LS Cranial Fixation Flap System | | Submission Number | K130309 | | Regulation Number | 21 CFR § 882.5250 | | Device Class | II | | Regulation Description | Burr hole cover | | Product Code | GXR | | Manufacturer | Biomet Microfixation | {5}------------------------------------------------ #### 4. Device Description The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone. The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use. The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use. #### 5. Indications for Use The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy. | Specification/ Characterization | Subject Device: Absorbable Cranial Flap Fixation System (K221606) | Predicate Device: RapidFlap LS Cranial Fixation Flap System (K130309) | Comments | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Indication for Use | The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy. | The RapidFlap LS Cranial Fixation Flap System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations. | Similar | | Material | Poly-L-lactic acid | Polylactic/polyglycolic acid copolymer | Similar | | Material property | Resorbable | Resorbable | Same | | Sterilization | Sterile by EO | Sterile by EO | Same | ## 6. Tabular Comparison of the Subject Device and Predicate Device {6}------------------------------------------------ | Specification/ Characterization | Subject Device: Absorbable Cranial Flap Fixation System (K221606) | Predicate Device: RapidFlap LS Cranial Fixation Flap System (K130309) | Comments | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------| | Component description | Lower disc and upper disc (each consisting of a circular disk with a threaded hole) connected by a connecting rod | Inner and outer plates (each consisting of a circular disk with a threaded hole) connected by a threaded central post | Similar | | Accessories | Battery operated Heat/Contouring Pen with cutting heating head and smoothing heating head | LactoSorb SE Heat Pen with cutting tip and contouring tip | Different | # 7. Summary of Non-clinical Testing The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The main performance of the product is tripping force, compression force and torque force and the test results showed no statistical difference between the subject device and predicate device. | Test | Test method summary | Results | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Tripping Force | The purpose of this test is to determine the locking function of the device is comparable to the predicate device. 1) The devices were fastened with the fixture of the tensile testing machine. 2) Apply tension at the stretching speed of 20 mm/min until the upper disc is released and record the tension force 3) Compared the test result of the subject and predicate device. | Pass No statistical difference between the predicate and subject device. | | Compression Force | 1) Place the upper/lower disk on the flat test bench. 2) Apply pressure to the disk with the microcomputer control electronic universal tester and record the maximum force required for the device to deform or crack. Compare the | Pass The acceptance criteria were met, and the results showed no statistical difference | {7}------------------------------------------------ | Test | Test method summary | Results | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | | results with the predicate and ensure that the acceptance criteria is met. | between the subject and predicate device. | | Torque Force | Clamp and fix both end of the connecting rod and rotate the connecting plate at a fixed rotational speed until the connecting rod is damaged or stops rotating and record the maximum force required for the connecting rod to break. | Pass No statistical difference between the subject and predicate device. | The biocompatibility evaluation for the Absorbable Cranial Flap Fixation System was conducted in accordance with the FDA guidance document "Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"". | Test | Results | Conclusion | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | In Vitro Cytotoxicity Test (ISO 10993-5:2009) | The percent cell viability of the subject device was 94.7% (>70%). | Pass Non - Cytotoxic | | Skin Sensitization Test (ISO 10993-10:2010) | Under the conditions of the study no visible change was observed in the test article groups. | Pass Non - Sensitizer | | Intracutaneous Reactivity Test (ISO 10993-10:2010) | Under the conditions of the study the overall mean score difference between the test article and vehicle was 0.56, less than 1.0. | Pass Non - Irritant | | Acute Systemic Test (ISO 10993-11:2017) | Under the conditions of the study the no toxic response was observed in the sample group. | Pass Not Systemically Toxic | | Material-Mediated Pyrogenicity (ISO 10993-11:2017) | The results showed that the body temperature of the three rabbits did not increase more than 0.5 °C. | Pass Not Pyrogenic | {8}------------------------------------------------ | Test | Results | Conclusion | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Bone Implantation Test (ISO 10993-6:2016) | Under the conditions of the study the histopathological response of the test article was similar with the control sample. | Pass | | Subchronic Systemic Toxicity (ISO 10993-11:2017) | Under the conditions of the study no toxic response was observed. | Pass No evidence of systemic toxicity | | Degradation Test (ISO 10993-13:2010) | Comparable results to the control group for blood lactate concentration, cerebrospinal fluid lactate concentration, pH, and histopathological. | Degradable and no toxicity | | Genotoxicity (ISO 10993-3:2014) | - The result of Ames test for the test article was negative. - The results indicated that the test sample could not induce chromosome aberrations. - The results showed that the test article did not induce gene mutation at TK locus. | Pass Non - genotoxic | The LAL endotoxin testing demonstrates that the sterile Absorbable Cranial Flap Fixation System conforms to the required ≤2.15 EU/device. ## 8. Conclusion The subject device, Absorbable Cranial Flap Fixation System, has the same intended use, design, function, and is composed of a similar material to the predicate device, RapidFlap LS Cranial Fixation Flap System. Based on the comparison of the technological and functions characteristics, intended use and performance data, the Absorbable Cranial Flap Fixation System is substantially equivalent to the predicate device, RapidFlap LS Cranial Fixation Flap System.