(87 days)
Not Found
No
The description focuses on the device being pre-formed based on CT scans and fixed with standard hardware, with no mention of AI/ML in the intended use, device description, or performance studies.
No.
The device is an implant designed to correct trauma and/or defects in bone, serving a structural or reconstructive purpose rather than directly delivering therapy or treatment.
No.
The device is an implant designed to correct trauma and defects, not to diagnose conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "pre-formed plate made of cured Simplex P bone cement," which is a physical, hardware component.
Based on the provided information, the Stryker® Patient Specific Polymer Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stryker Patient Specific Polymer Implant is a physical implant designed to correct bone defects. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to correct trauma and/or defects in bone, not to perform diagnostic testing on biological samples.
- Device Description: The description clearly states it's a pre-formed plate made of bone cement, fixed with plates and screws. This is a physical medical device, not a diagnostic test kit or instrument.
Therefore, the Stryker Patient Specific Polymer Implant falls under the category of a medical device (specifically, an implantable device), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Product codes (comma separated list FDA assigned to the subject device)
KKY, GWO
Device Description
The Stryker Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
mandibular, maxillofacial, or craniofacial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 Stryker Patient Specific Polymer Implant has been verified and validated according Stryker procedures for product design and development. The validation proves the safety and effectiveness of the system.
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
JUL 1 4 2011
510(k) Summary
| Name and Address of Sponsor: | Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Claudia Wiesemann
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
D-79111 Freiburg
Germany
Phone: (+49) 761 45 12 4093
Fax: (+49) 761 4512 49 283
Email: claudia.wiesemann@stryker.com |
| Date Summary Prepared: | April 14, 2011 |
| Device Trade Name: | Stryker® Patient Specific Polymer Implant |
| Common Name: | Preformed Alterable Cranioplasty Plate, PMMA |
| Classification Name and Reference: | Polytetrafluoroethylene with carbon
fibers composite
implant material, 21 CFR §878.3500
Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Proposed Regulatory Class: | Class II |
| Product Code: | KKY, GWO |
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Stryker® Patient Specific Polymer Implant components with an online ordering system.
Indications for Use:
The Stryker Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Proposed Modification:
The product will now be supplied with an online ordering system called eRequest Lifecycle. The manufacturing location and processes have not changed since originally described in K103010.
Device Description:
The Stryker Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
Substantial Equivalence:
The Stryker Patient Specific Polymer Implant has been verified and validated according Stryker procedures for product design and development. The validation proves the safety and effectiveness of
1
K11063
f9 2/2
the system. The information provided by Stryker in this 510(k) application was found to be substantially equivalent with predicate devices such as the 510(k) clearance of:
The following matrix demonstrates the substantially equivalence of the Stryker® Patient Specific Polymer Implant with the two predicates (K103010 and K083621).
| | Stryker® Patient
Specific Polymer
Implant | Stryker® Patient
Specific Polymer
Implant | MEDPOR Customized
Surgical. Implant |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | Subject Device | Predicate Device I | Predicate Device II |
| 510(k) Number | | K103010 | K083621 |
| Indications for
Use | The Stryker Patient
Specific Polymer
Implant is designed
individually for each
patient to correct trauma
and/or defects in
mandibular,
maxillofacial, or
craniofacial bone. | The Stryker Patient
Specific Polymer
Implant is designed
individually for each
patient to correct trauma
and/or defects in
mandibular,
maxillofacial, or
craniofacial bone. | The MEDPOR
Customized Surgical
Implant is intended for
the augmentation or
restoration of bony
contour in craniofacial
defects. |
| Product Code | KKY, GWO | KKY, GWO | JOF, GWO |
| Material/Chemical
composition | Simplex P Bone Cement | Simplex P Bone Cement | A linear, high-density
polyethylene biomaterial |
| Ordering System | | | |
| Request Initiation | | | |
| Fax/Mail Order | X | X | X |
| Online Order | X | - | X |
| Image Data Transfer | | | |
| CD on disk via mail | X | X | X |
| Online Upload
(Password
protected) | X | | X |
| Design Approval | | | |
| Fax/Mail Approval | X | X | X |
| Online Approval
(Password
protected) | X | - | X |
| Online assessment
of virtual implant | X | - | X |
| Use of CT scans | X | X | X |
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized human figure with three overlapping bodies, and the text "DEPARTMENT OF HEALTH &" is written vertically along the left side of the figure. The text is oriented so that it reads from bottom to top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. dba Stryker Orthopedics c/o Ms. Claudia Wiesemann Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
JUL 1 4 2011
Re: K111065
Trade/Device Name: Stryker® Patient Specific Polymer Implant Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, KKY Dated: April 14, 2011 Received: April 18, 2011
Dear Ms. Wiesemann:
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.
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
3
Page 2 - Ms. Claudia Wiesemann
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Keoia Alexander
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
4
Indications for Use
KIII065 510(K) Number (if known): _
Device Name: Stryker® Patient Specific Polymer Implant
Indications for Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111065