(60 days)
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement.
The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a validated Stryker PMMA bone cement, such as Stryker VertaPlex® or VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack but are sold separately.
This document is a 510(k) premarket notification decision letter from the FDA regarding the SpineJack® Expansion Kit. It primarily addresses changes to the device's contraindications, specifically the removal of Type A trauma fractures, rather than providing detailed acceptance criteria and performance data for a new device or a device involving AI.
Therefore, the information required to answer your request about acceptance criteria and study proving device meets acceptance criteria (especially for an AI/software device) is NOT present in the provided text. The document explicitly states:
- Non-Clinical Testing: "Non-clinical testing was deemed not required for this 510(k). The SpineJack implant was previously tested to be non-pyrogenic."
- Clinical Testing: "Clinical testing was deemed not required for this 510(k)"
- Other Evidence: "Clinical literature, post-market surveillance data and a risk analysis per ISO 14971 were used in support of the subject modification."
This indicates that the submission is for a modification to an existing device (SpineJack Predicate Device, K181262), and the FDA determined that no new testing (clinical or non-clinical) was needed to establish substantial equivalence for the change (removal of Type A trauma fractures from contraindications). Instead, the decision was based on existing clinical literature, post-market data, and risk analysis.
Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone performance, as this kind of data is not provided in the document. The document is a regulatory approval letter for a device modification, not a study report.
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October 20, 2020
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Stryker Corporation Kristi Ashton Senior Staff RA Specialist 1926 Stryker Way Kalamazoo, Michigan 49002
Re: K202393
Trade/Device Name: SpineJack® Expansion Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: August 18, 2020 Received: August 21, 2020
Dear Kristi Ashton:
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
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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,
for
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
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Indications for Use
510(k) Number (if known) K202393
Device Name
SpineJack® Expansion Kit (Spinejack ®)
Indications for Use (Describe)
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement.
| 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) |
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510(K) SUMMARY
| 510(K) SUMMARY: SPINEJACK® EXPANSION KIT | |
|---|---|
| Submitter: | Stryker Instruments1941 Stryker WayKalamazoo, MI 49002 USAContact Name: Kristi AshtonTitle: Senior Staff RA SpecialistPhone: 269-800-1692E-mail: Kristi.Ashton@Stryker.com |
| Date prepared: | October 20, 2020 |
| Subject Device Trade Name: | SpineJack Expansion Kit (SpineJack) |
| Common Name: | Implantable Fracture Reduction System |
| Classification Name: | Cement, Bone, Vertebroplasty |
| Product Code: | NDN |
| Regulatory Class: | II |
| Regulation Name: | Polymethylmethacrylate (PMMA) |
| Regulation Number: | 21 CFR 888.3027 |
| Predicate Device: | SpineJack Expansion Kit (SpineJack), K181262 |
| Device Description: | The SpineJack Expansion Kit (herein referred to as “SpineJack”) is animplanted fracture reduction system, intended to reduce vertebralcompression fractures. The SpineJack Expansion Kit is used with thePreparation Kit. The Expansion Kit is available in three sizes, toaccommodate different vertebral body sizes, Ø4.2mm, Ø5mm, andØ5.8mm. After the SpineJack implant is inserted, it is expanded, and avalidated Stryker PMMA bone cement, such as Stryker VertaPlex® orVertaPlex® HV Bone Cement, is injected at a low pressure to stabilizethe restored vertebral body. The bone cement and its delivery system areintended to be used with the SpineJack but are sold separately. |
| Indications for Use | The SpineJack® Expansion Kit is indicated for use in the reduction ofpainful osteoporotic vertebral compression fractures. It is intended to beused in combination with Stryker Vertaplex® and Vertaplex® HV BoneCement. |
| Non-Clinical Testing | Non-clinical testing was deemed not required for this 510(k). TheSpineJack implant was previously tested to be non-pyrogenic. |
| Clinical Testing | Clinical testing was deemed not required for this 510(k) |
| Other Evidence: | Clinical literature, post-market surveillance data and a risk analysis perISO 14971 were used in support of the subject modification. |
| Summary of Technological Characteristics |
Table 1 below details the comparisons between the subject and predicate devices.
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| Table 1 Comparison of Regulatory and Technical Characteristics | ||||
|---|---|---|---|---|
| Element ofComparison | SpineJackSubject Device | SpineJackPredicate Device | Comparison | |
| Indications for Use | The SpineJack®Expansion Kit isindicated for use in thereduction of painfulosteoporotic vertebralcompression fractures. Itis intended to be used incombination withStryker Vertaplex® andVertaplex® HV bonecements. | The SpineJack®Expansion Kit isindicated for use in thereduction of painfulosteoporotic vertebralcompression fractures.It is intended to be usedin combination withStryker Vertaplex® andVertaplex ® HV bonecements. | Identical | |
| Contraindications | Patients presenting withtype B or C traumaticvertebral fracturesaccording to the Magerlclassification. | Patient presenting withtraumatic fractures(Reference IFU for fulllist of contraindications) | Different-It is proposedthat Type A traumafractures are removedfrom the list ofcontraindications forSpineJack. Clinicalliterature, post-market dataand a risk assessment perISO 14971 were providedto support the safety ofthis modification. Thischange does not raise newtypes of safety andeffectiveness questionsregarding the use of thesubject device. | |
| Contact | Implantable | Implantable | Identical | |
| Material | Ti-6Al-4V with PMMA(cement injected) | Ti-6Al-4V with PMMA(cement injected) | Identical | |
| Length (mm) | 14 - 20 (plate length) | 14 - 20 (plate length) | Identical | |
| Width (mm) | 4 - 6 | 4 - 6 | Identical | |
| Height pre and postexpansion (mm) | 4 - 20 (Surgeondetermined) | 4 - 20 (Surgeondetermined) | Identical | |
| Expansion Mechanism | Plastic deformation ofstruts, continuous | Plastic deformation ofstruts, continuous | Identical | |
| Number of ImplantsTypically Used | 1-2 per patient | 1-2 per patient | Identical |
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SpineJack has the same intended use, fundamental scientific technology, principle of operation, and mode of action as the predicate device. An evaluation of clinical literature, post-market data in US and Europe and risk per ISO 14971 provide the evidence to support the removal of Type A trauma fractures from the contraindications. The use of post-market data from Europe demonstrates the history of safe and effective use of the Conclusion product in Type A traumatic fractures since 2008. The evaluation of the post-market data, use history and a clinical literature review provide established evidence which confirm that the subject modification does not raise new types of safety and effectiveness questions regarding the use of the subject device. Therefore, it is proposed that the subject SpineJack is equivalent to the predicate device.
§ 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.”