(119 days)
K#072601, K#053199, K#033868
Not Found
No
The description focuses on custom manufacturing based on CT scans and mechanical testing, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a prosthetic implant designed to correct defects in cranial bone, not to provide therapy.
No
The device is a prosthetic implant used to correct defects in cranial bone, not to diagnose medical conditions. Its purpose is to treat or correct, not to identify or detect.
No
The device description explicitly states the device is a prosthetic cranioplasty implant manufactured from PEEK, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "correct defects in cranial bone" by providing a physical implant. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "prosthetic cranioplasty implant" made from PEEK. It is a physical object implanted into the patient.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a medical implant used for structural repair.
N/A
Intended Use / Indications for Use
OsteoSymbionics PEEK Patient-Specific Cranial Implants are designed individually for each patient to correct defects in cranial bone.
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
cranial bone
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)
The PEEK materials are shown to be biocompatible and that manufacturing processes due not introduce risk of contamination.
The software used to facilitate the difference in manufacturing process between the original PMMA device and the PEEK device made by OsteoSymbionics has been validated.
Mechanical testing has shown the PEEK implant to be comparable to the PMMA implant made by OsteoSymbionics.
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.
K#072601, K#053199, K#033868
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).
0
K121102 :
8 2012
page 1 of 3
510(K) SUMMARY
Submitted on behalf of:
| Company Name:
Address: | OsteoSymbionics, LLC.
1768 East 28th Street
Cleveland, OH 44114 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | 216-881-8500
216-391-7004 |
| by: | Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082 |
| Telephone:
Fax: | 715-549-6035
715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | July 3, 2012 |
| TRADE NAME: | OsteoSymbionics PEEK Patient-Specific
Cranial Implant |
| COMMON NAME:
CLASSIFICATION NAME:
PRO CODE: | Cranial Plate
Plate, Cranioplasty, Preformed, Non-Alterable
GXN |
SUBSTANTIALLY EQUIVALENT TO:
The OsteoSymbionics PEEK Patient Specific Cranial Implants are substantially equivalent to: 1) OsteoSymbionics Patient Specific Cranial Implants made from PMMA (K#072601) and 2) Synthes (USA) Patient Specific Cranial/Craniofacial Implants made from PEEK (K#053199 and K#033868).
| Device
Characteristics | OsteoSymbionics
PMMA | Synthes
PEEK | OsteoSymbionics
PEEK |
|------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------|
| Classification
Regulation | 21 CFR § 882.5330 | 21 CFR § 882.5330 | SAME |
| Classification
Name (Product
Code) | Preformed Non-
alterable
Cranioplasty Plate
(GXN) | Synthes (USA)
Patient Specific
Cranial/Craniofacial
Implants (from
PEEK) (GXN) | SAME |
1
K121102
age 2 of 3
510(k) Summary-Continued
| Device
Characteristics | OsteoSymbionics
PMMA | Synthes
PEEK | OsteoSymbionics
PEEK |
|---------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------|
| Device
Description | Individually sized
and shaped
implantable
prosthetic
cranioplasty plates | Individually sized
and shaped
implantable
prosthetic
cranioplasty plates | SAME |
| Intended Use | To correct defects
in craniofacial
bone. | To replace bony
voids in the
cranial/craniofacial
skeleton. | SAME |
| Design | Patient specific | Patient specific | SAME |
| Attachment
Method | Attached to native
bone with
commercially
available
cranioplasty
fasteners. | Attached to native
bone using
standard Synthes
cranial and
craniofacial plates
and screws. | SAME |
The significant differences between the OsteoSymbionics PEEK Patient Specific Cranial Implant to the predicate made from PMMA is of course, the material PEEK, and the manufacturing methods used to make the PEEK plates compared to the processing of PMMA. The Synthes cranial implants made from PEEK preceded The OsteoSymbionics PEEK Patient Specific Cranial Implants, as have other PEEK cranial plates (not listed herein as predicates.)
DESCRIPTION of the DEVICE:
OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.
INTENDED USE: OsteoSymbionics PEEK Patient-Specific Cranial Implants are designed individually for each patient to correct defects in cranial bone.
2
510(k) Summary-Continued
INDICATIONS FOR USE:
OsteoSymbionics PEEK Patient-Specific Cranial Implants are designed individually for each patient to correct defects in cranial bone.
SUMMARY of Testing and Basis for Substantial Equivalence:
OsteoSymbionics PEEK Patient-Specific Cranial Implants are manufactured from PEEK and provided non-sterilization prior to implantation. The sterilization instructions on the instruction for use have been validated.
The PEEK materials are shown to be biocompatible and that manufacturing processes due not introduce risk of contamination.
The software used to facilitate the difference in manufacturing process between the original PMMA device and the PEEK device made by OsteoSymbionics has been validated.
Mechanical testing has shown the PEEK implant to be comparable to the PMMA implant made by OsteoSymbionics.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 8 . 2012
OsteoSymbionics, LLC. c/o Ms. Elaine Duncan President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082
Re: K121102
Trade/Device Name: OsteoSymbionics PK Shield (PEEK Patient-Specific Cranial Implant) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: July 27, 2012 Received: July 30, 2012
Dear Ms. Duncan:
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. 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.
4
Page 2 - Ms. Elaine Duncan
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 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexa
Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant)
Indications for Use:
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Brvision Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121102
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