(28 days)
Not Found
No
The summary describes a patient-specific implant manufactured from standard materials and attached with standard hardware. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML in the design or manufacturing process.
No
The device is described as an implant to replace bony voids, which is a structural replacement, not a therapeutic treatment.
No
Explanation: The device description states its purpose is to "replace bony voids," which is a treatment or reconstruction function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states the implant is manufactured from CP Titanium and PEEK, which are physical materials, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Synthes Patient Specific Cranial/Craniofacial Implant is a physical implant designed to replace bone in the skull and face. It is surgically implanted into the patient.
- Intended Use: The intended use is to replace bony voids in the cranial/craniofacial skeleton, which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgically implanted device, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial/craniofacial skeleton
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
The Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) replaces bony voids in the cranial/craniofacial skeleton. Multi-piece implants are preformed / pre-shaped to fit the anatomy of the patient, will range in size from 100 x 100 mm to 350 x 350 mm, and attach to the native bone using standard Synthes cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm. The Synthes Patient Specific Cranial/Craniofacial Implants are manufactured from CP Titanium and PEEK.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial/craniofacial skeleton
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)
Not Found
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the date December 14, 2005. The month is abbreviated to DEC. The numbers are clearly printed in a simple font. The image is a close-up of the date.
@SYNTHES®
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K053199 -______________________________________________________________________________________________________________________________________________________________________________
| 510(k) Summary | Page 1 of 1 | |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Device Name: | Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) | |
| Classification: | Class II § 21 CFR 882.5330: Plate, Cranioplasty, preformed, non-alterable | |
| Predicate Devices: | Synthes Patient Specific Cranial/Craniofacial Implant, | |
| K033868 | ||
| Porex Medical: MEDPOR Porous Polyethylene Cranial | ||
| Implants, K832283 | ||
| Device Description: | The Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) replaces bony voids in the cranial/craniofacial skeleton. Multi-piece implants are preformed / pre-shaped to fit the anatomy of the patient, will range in size from 100 x 100 mm to 350 x 350 mm, and attach to the native bone using standard Synthes cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm. The Synthes Patient Specific Cranial/Craniofacial Implants are manufactured from CP Titanium and PEEK. | |
| Intended Use: | Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial/craniofacial skeleton | |
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
:
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
Ms. Kathleen Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K053199
Trade/Device Name: Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: November 15, 2005 Received: November 16, 2005
Dear Ms. Anderson:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kathleen Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace gacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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ﮐﮯ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A registered trademark symbol is to the right of the word.
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| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K05 3199 |
|---|---|
| Device Name: | Synthes (USA) Patient Specific Cranial/Craniofacial Implant |
| Indications for Use: |
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.
Prescription Use X AND/OR (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053199
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