(264 days)
No
The device description and performance studies focus on the material properties and mechanical performance of bone cement and pedicle screws, with no mention of AI or ML.
Yes
The device, through its components BonOs® Inject bone cement and NEO Pedicle Screw System™, directly treats pathological fractures, restores spinal integrity, and provides immobilization and stabilization for various spinal conditions, fitting the definition of a therapeutic device.
No.
The device is a bone cement and a pedicle screw system used for surgical treatment of vertebral body fractures and spinal stabilization, not for diagnosing medical conditions.
No
The device description clearly outlines physical components: bone cement (powder and liquid) and pedicle screws and rods made of titanium alloy. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for treating pathological fractures of the vertebral body and stabilizing spinal segments through surgical procedures (vertebroplasty, kyphoplasty, pedicle screw fixation). This is a therapeutic and structural intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device description details a bone cement and a pedicle screw system, both of which are physical implants and materials used directly within the patient's body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant and material used for structural support and stabilization within the spine.
N/A
Intended Use / Indications for Use
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.
When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.
When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes
PML, NDN, NKB
Device Description
BonOs® Inject:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
Neo Pedicle Screw System™:
The Neo Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.
The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body, thoracic and lumbar spine, spinal segments, non-cervical
Indicated Patient Age Range
skeletally mature patients
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)
No changes were made to the existing devices BonOs® Inject (K090460) and Neo Pedicle Screw System™ (K171582). Therefore, no additional testing was required or performed.
To demostrate substantial equivalence to the additional predicate device Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set (K191148, S.E. 09/12/2019), axial pullout strength according to ASTM F2193 / ASTM F543, cement flow and bolus formation were tested.
Additionally, Bacterial endotoxins of BonOs® Inject have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.1.10 and 2.6.32 (draft), based on USP . Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016). This test for bacterial endotoxins is performed for all produced batches. The device meets the pyrogen limit specifications as described by the FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016).
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.
K152604, K170347, K191148, K090460
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.
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.”
0
May 18, 2021
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osartis GmbH Volker Stirnal Director Quality Assurance and Regulatory Affairs Auf der Beune 101 Münster, 64839 Germany
Re: K202458/S001
Trade/Device Name: BonOs® Inject, Neo Pedicle Screw System™ Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NDN, NKB Dated: April 16, 2021 Received: April 19, 2021
Dear Volker Stirnal:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Laura C. Rose, 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
2
Indications for Use
510(k) Number (if known) K202458
Device Name BonOs® Inject
Indications for Use (Describe)
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.
When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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.
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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."
3
Indications for Use
510(k) Number (if known) K202458
Device Name NEO Pedicle Screw System™
Indications for Use (Describe)
The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.
When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
| 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 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) Premarket Notification
page 1 of 4
5. 510(k) Summary
1. General Information
1.1 Submitter and Owner of the 510(k)
OSARTIS GmbH Auf der Beune 101 64839 Münster Germany Phone: +49 6071 / 929-0 Fax: +49 6071 / 929-100
1.2 Contact Person
Volker Stirnal
1.3 Device Subject of this 510(k)
BonOs® Inject Bone Cement, Neo Pedicle Screw System™
1.4 Date of Preparation
20.08.2020
2. Name of the Device and Classification Information
This traditional 510(k) has been submitted for the following device. BonOs® Inject Bone Cement, Neo Pedicle Screw System™
2.1 Trade/Proprietary Name
BonOs® Inject Bone Cement, Neo Pedicle Screw System™
2.2 Common/Usual Name
PMMA bone cement for vertebroplasty, Bone Screw, Pedicle Screw
2.3 Classification Information
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement,
Vertebroplasty, Bone Cement Posterior Screw
Augmentation |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| Classification Regulation: | 21 CFR § 888.3027 |
| Regulatory Class: | Class II |
| Product Code: | PML, NDN |
| Panel: | Orthopedic |
5
510(k) Premarket Notification
page 2 of 4
Subsequent Product Codes (if any):
NKB Neo Pedicle Screw System™ 21 CFR § 888.3070 Class II
3. Predicate Device
Subject devices
- -BonOs® Inject
- Neo Pedicle Screw System™ -
Predicate Device
- Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD -Horizon™ Fenestrated Screw Set (510(k) applications K152604, S.E., 01/06/2016; K170347, S.E. 04/04/2017 and K191148, S.E. 09/12/2019)
Additional Predicate Device
- BonOs® Inject (510(k) application (K090460, S.E.04/14/2009) -
Reference Device
- -Neo Pedicle Screw System™ (510(k) application K171582, S.E. 09/12/2017)
4. Device Description
BonOs® Inject:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
Neo Pedicle Screw System™:
The Neo Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.
The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5.
6
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
Germany | BonOs® Inject, Neo Pedicle
Screw System™
5. 510(k) Summary | Date of issue:
2020-10-21 |
|---------------------------------------------------------------|------------------------------------------------------------------|------------------------------|
| | 510(k) Premarket Notification | page 3 of 4 |
All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.
5. Indication for Use
BonOs® Inject:
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.
When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Neo Pedicle Screw System™:
The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, noncervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic oriqin with degeneration of the disc confirmed by history and radioqraphic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.
When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
6. Comparison of the technological Characteristics with the Predicate Device
The subject devices BonOs® Inject and Neo Pedicle Screw System™ are the same as the currently cleared BonOs® Inject (K090460, S.E.04/14/2009) and Neo Pedicle Screw System™ (K171582, S.E. 09/12/2017). There are no technology changes to the existing cleared devices. The subject devices have the same overall design, packaging, sterilization and materials as the currently cleared devices.
The additional predicate device for the subject device BonOs® Inject is BonOs® Inject (K090460, S.E.04/14/2009). The subject BonOs® Inject has the same or similar intended use, same or similar overall design, packaging, sterilization and materials as
7
510(k) Premarket Notification
the following FDA additional predicate cleared in K090460 (S.E.04/14/2009). The predicate and subject have the identical function and scientific fundamental technology. There are no technology changes to the existing predicate device BonOs® Iniect.
However, when used in combination, BonOs® Inject and the Neo Pedicle Screw System™ labeling has been updated to reflect the same indications for use as the predicate device Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set (K191148, S.E. 09/12/2019).
The expanded indications enable the BonOs® Iniect cement to be delivered through the cannulated fenestrated screws of the Neo Pedicle Screw System™ for a controlled flow of cement into the pedicle. After a screw is placed posteriorly, the cement is delivered through the cannulated screw and distal fenestrations. The cement hardens over time.
The Neo Pedicle Screw System™ is similar to the Medtronic CD Horizon™ Fenestrated Screw Set. The screw design of the subject device is similar to the predicate with cannulations and side fenestrations at the distal tip to allow cement delivery.
The subject devices are already used together for cement auqmentation outside the United States.
7. Performance Data
No changes were made to the existing devices BonOs® Inject (K090460) and Neo Pedicle Screw System™ (K171582). Therefore, no additional testing was required or performed.
To demostrate substantial equivalence to the additional predicate device Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set (K191148, S.E. 09/12/2019), axial pullout strength according to ASTM F2193 / ASTM F543, cement flow and bolus formation were tested.
Additionally, Bacterial endotoxins of BonOs® Inject have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.1.10 and 2.6.32 (draft), based on USP . Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016). This test for bacterial endotoxins is performed for all produced batches. The device meets the pyrogen limit specifications as described by the FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016).
8. Conclusion
BonOs® Inject and Neo Pedicle Screw System™ have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices.