(147 days)
Not Found
No.
The document describes a medical device for
delivering bone cement. It makes no mention of AI models, machine learning, or deep neural networks. The performance studies focus on sterilization, shelf life, and biocompatibility, not AI model validation.
Yes
The device, a spinal bone cement system, is intended for the treatment of pathological fracture of the vertebral body using vertebroplasty or kyphoplasty, which are therapeutic procedures aimed at alleviating pain and stabilizing the vertebra.
No.
The device is a bone cement system and delivery system used for the treatment of vertebral body fractures, not for diagnosing conditions.
No
The device is a system composed of bone cement (PMMA-styrene copolymer powder and methyl methacrylate liquid) and a delivery system including a bone cement mixing device and a hydraulic pump. These are physical materials and mechanical components, not software. The performance studies and descriptions focus on physical characteristics like sterilization, shelf life, and biocompatibility, as well as the functionality of physical components, with no mention of software or digital processing.
No.
The device is a spinal bone cement system and delivery system used for the treatment of vertebral fractures, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.
Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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)
All the pre-clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device.
The following non-clinical tests were performed on the delivery system.
Sterilization and Shelf Life: The Sterilization complies with ISO 11137. Product shelf-life testing was evaluated to ensure the labeled shelf life.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible, and suitable for their intended use. The following biocompatibility studies were completed.
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Systemic Toxicity (acute)
- Material-mediated Pyrogenicity
Test data supports the shelf life and biocompatibility of the delivery system.
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.
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.
Not Found
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 11, 2025
XELITE BIOMED LTD.
Mandy Lin
Regulatory Affairs Specialist
2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist., New Taipei City 231,
Taiwan (R.O.C.)
New Taipei City, 231022
Taiwan
Re: K243537
Trade/Device Name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Regulation Number: 21 CFR 888.3027
Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement
Regulatory Class: Class II
Product Code: NDN
Dated: November 15, 2024
Received: March 14, 2025
Dear Mandy Lin:
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"
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K243537 - Mandy Lin Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K243537 - Mandy Lin Page 3
Sincerely,
Robert M. Stefani -S
Digitally signed by Robert M. Stefani -S
Date: 2025.04.11 15:20:49 -04'00'
For: Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative, Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243537
Device Name
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Indications for Use (Describe)
The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).
Type of Use (Select one or both, as applicable)
☒ 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
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"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."
Page 5
510(k) Summary
510(k) SUMMARY
1. Submission Information
Submitter: XELITE BIOMED LTD.
2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist.,
New Taipei City 231, Taiwan (R.O.C.) New Taipei City
231022 Taiwan
Submitter contact: Mr. Wei Chun Chang
Tel: +886-912111529
E-mail: raychang@xelitemd.com
Prepared date: 2025-03-12
2. Device Name and Classification
Product Name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Classification Name: Cement, Bone, Vertebroplasty
Common or Usual Name: Polymethylmethacrylate (PMMA) bone cement
Regulation Number: 888.3027
Product Code: NDN
3. Predicate Device(s)
Product Name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement (HSA0125/HSA0200/HSA0250) (K241775)
Common or Usual Name: Polymethylmethacrylate (PMMA) bone cement
Regulation Number: 888.3027
Product Code: NDN
4. Device Description
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.
Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and
K243537
1
Page 6
transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.
5. Indications for Use
The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).
6. Comparison to the Predicate Device
The subject device maintains the design characteristics of the predicate device. Its indications for use and materials remain consistent with the predicate device. The only difference is the subject device is provided with an additional Class I hand-operated delivery system.
7. Performance Data
All the pre-clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device.
The following non-clinical tests were performed on the delivery system.
Sterilization and Shelf Life: The Sterilization complies with ISO 11137. Product shelf-life testing was evaluated to ensure the labeled shelf life.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible, and suitable for their intended use. The following biocompatibility studies were completed.
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Systemic Toxicity (acute)
- Material-mediated Pyrogenicity
8. Conclusion
Evaluation of the subject device's intended use and technological characteristics
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demonstrates substantial equivalence with the predicate device. Test data supports the shelf life and biocompatibility of the delivery system.
3