OSSDSIGN Cranial PSI

K212414 · Ossdsign AB · PJN · Oct 1, 2021 · Neurology

Device Facts

• Record ID: K212414
• Device Name: OSSDSIGN Cranial PSI
• Applicant: Ossdsign AB
• Product Code: PJN · Neurology
• Decision Date: Oct 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

Device Story

Patient-specific cranial implant; replaces native bone in cranial skeleton. Composed of rigid titanium mesh covered by biocompatible calcium phosphate ceramic tiles in mosaic pattern. Ceramic component resorbs; replaced by bone during healing. Mosaic pattern allows fluid circulation. Implant created based on patient's unique anatomical requirements. Used by surgeons for cranial reconstruction. Provides structural support for non-load bearing defects; promotes osteoconduction.

Clinical Evidence

Bench testing and in vivo data provided. 52-week sheep implantation study (ISO 10993-6) demonstrated biocompatibility, adequate resorption rate, and osteoconduction.

Technological Characteristics

Materials: Grade 23 titanium, proprietary calcium phosphate ceramic. Form: Patient-specific preformed plate, 0.4–1.6 mm titanium thickness, max size 200 cm². Sterilization: Sterile delivery. Connectivity: None.

Indications for Use

Indicated for reconstruction of cranial defects in patients with complete cranial growth; requires intact dura (with or without duraplasty); for non-load bearing osseous defects (surgically created or traumatic).

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• OSSDSIGN Cranial PSI (K161090)

Submission Summary (Full Text)

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October 1, 2021

OssDsign AB % David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, Florida 32043-3443

Re: K212414

Trade/Device Name: OSSDSIGN Cranial PSI Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: July 30, 2021 Received: August 3, 2021

Dear David Weissburg:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K212414

Device Name OSSDSIGN Cranial PSI

#### Indications for Use (Describe)

OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

Type of Use (Select one or both, as applicable)

| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) SUMMARY

## K212414

- 1. 510(k) Owner Name and Address: OSSDSIGN AB Rapsgatan 23A SE 754 50, Uppsala Sweden Telephone: [phone] Email: [e-mail] Contact: Jonas Åberg
- 2. Contact Person: David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, FL 32043-3443 USA
- 3. Date prepared: October 1, 2021
- 4. Trade Name: OSSDSIGN Cranial PSI
- 5. Regulation Description: Preformed Non-alterable Cranioplasty Plate
- 6. Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN)
- 7. Class: 2
- 8. Predicate Device: OSSDSIGN Cranial PSI (K161090)
- 9. Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
- 10. Indications for Use: OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
- 11. Comparison of Technological Characteristics with the Predicate Device: The subject device is identical to cleared predicate device OssDsign Cranial PSI K161090 in every way except the proposed labeling change.

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| | OSSDSIGN<br>Cranial PSI (K212414, subject<br>device) | OSSDSIGN<br>Cranial PSI (K161090, predicate) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>For Use | OSSDSIGN Cranial PSI is an<br>implant intended for the<br>reconstruction of cranial defects.<br>These osseous defects are<br>surgically created or the result of<br>traumatic injury to the bone and<br>are not intrinsic to the stability of<br>the bony structure. The ceramic<br>component of Cranial PSI resorbs<br>and is replaced with bone during<br>the healing process. Cranial PSI is<br>indicated for use in patients in<br>whom cranial growth is complete<br>and for use with an intact dura,<br>with or without duraplasty. | OSSDSIGN Cranial PSI is<br>intended for the reconstruction of<br>cranial defects. It is indicated for<br>non-load bearing applications for<br>patients in whom cranial growth is<br>complete and for use with an intact<br>dura, with or without duraplasty. |
| | the healing process. Cranial PSI is<br>indicated for use in patients in<br>whom cranial growth is complete<br>and for use with an intact dura,<br>with or without duraplasty. | |
| Materials | Ti grade 23, proprietary calcium<br>phosphate ceramic | Ti grade 23, proprietary calcium<br>phosphate ceramic |
| Titanium<br>thickness | 0.4 – 1.6 mm | 0.4 – 1.6 mm |
| Max size | 200 cm² | 200 cm² |
| Provided form | Titanium and Ceramic<br>Ceramic mixed and cured in<br>manufacturer's facility | Titanium and Ceramic<br>Ceramic mixed and cured in<br>manufacturer's facility |
| Sterility on<br>delivery | Sterile | Sterile |

### 12. Performance Testing:

| Test | Test Method Summary | Results |
|-------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------|
| in vivo<br>implantation | 52-week sheep implantation study,<br>ISO 10993-6 | in vivo studies show<br>biocompatibility, adequate<br>resorption rate and<br>osteoconduction. |

### 13. Conclusion:

Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device.