(90 days)
Lorenz LactoSorb® Trauma Plating System (Biomet), Synthes Resorbable Fixation System, Poly (L/DL-lactide)
Not Found
No
The summary describes a resorbable fixation system made of a specific polymer, intended for mechanical fixation in craniofacial surgery. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device description focuses on the physical properties and application of the implants.
Yes
Explanation: The device is intended for "fracture repair and reconstructive procedures" and "aids in the alignment and stabilization of craniofacial bones," which directly addresses and treats medical conditions or injuries, qualifying it as therapeutic.
No
Explanation: This device is a resorbable fixation system (plates, meshes, sheets, and screws) used for fracture repair and reconstructive procedures of the craniofacial skeleton, which indicates it is a therapeutic or surgical device, not a diagnostic one. It aids in alignment and stabilization, rather than in identifying or characterizing a medical condition.
No
The device description explicitly states the system consists of physical components (Plates, Meshes, Sheets, and Screws) made of a resorbable material, indicating it is a hardware device, not software-only.
No, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a system of resorbable plates, meshes, sheets, and screws made of Poly (L-Lactide-co-Glycolide). These devices are intended for surgical implantation to fix fractures and aid in reconstruction of the craniofacial skeleton.
- Mechanism of Action: The device works by providing physical support and fixation to bone fragments, not by analyzing biological samples.
The device described is a surgical implant used directly on the patient's body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System devices (Plates, Meshes, Sheets and Screws) are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets and Screws may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
Product codes
JEY
Device Description
Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System consists of Plates, Meshes, Sheets and Screws. The system is provided in a variety of shapes and sizes and, when used in conjunction with resorbable screws, the system provides fixation and aids in the alignment and stabilization of craniofacial bones. To facilitate shaping to the contours of the anatomy, the thermoplastic implants may be heated above the glass transition temperature of 55° C or they may be cut to the desired shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, craniofacial or mandibular areas
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)
Lorenz LactoSorb® Trauma Plating System (Biomet), Synthes Resorbable Fixation System, Poly (L/DL-lactide)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
APR 0 8 2003
:
K030069
| 2. 510(k) Summary | Page 1 of 1 |
|---|---|
| Submitter: | Synthes (USA) 1690 Russell Road, Paoli, PA 19301 |
| Company Contact: | Bonnie J. Smith |
| (610) 647-9700 | |
| Name of Device: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| Device Classification / | |
| Common Name: | Class II, 21 CFR §872.4760 - Bone Plate |
| Class II, 21 CFR §888.3030 - Screw Fixation, Intraosseous | |
| Predicate Device: | Lorenz LactoSorb® Trauma Plating System (Biomet) and Synthes |
| Resorbable Fixation System, Poly (L/DL-lactide) | |
| Intended Use: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| devices (Plates, Meshes, Sheets and Screws) are intended for use in | |
| fracture repair and reconstructive procedures of the craniofacial skeleton. | |
| In addition, Resorbable Meshes, Sheets and Screws may be used in non- | |
| load bearing applications for maintaining the relative position of and/or | |
| containing bony fragments, bone grafts (autograft or allograft) or bone | |
| graft substitutes in reconstruction of the craniofacial or mandibular areas. | |
| Contraindications: | These devices are not intended for use in full load bearing applications, |
| such as the mandible, unless used in conjunction with traditional rigid | |
| fixation. Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation | |
| System devices are not intended for areas with active or latent infection or | |
| for patient conditions including limited blood supply or insufficient | |
| quantity or quality of bone. These devices are not intended for use in the | |
| spine. | |
| Device Description: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| consists of Plates, Meshes, Sheets and Screws. The system is provided in a | |
| variety of shapes and sizes and, when used in conjunction with resorbable | |
| screws, the system provides fixation and aids in the alignment and | |
| stabilization of craniofacial bones. To facilitate shaping to the contours of | |
| the anatomy, the thermoplastic implants may be heated above the glass | |
| transition temperature of 55° C or they may be cut to the desired shape. |
1
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in a sans-serif font and is evenly spaced around the curve.
APR 0 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K030069
Trade/Device Name: Sythes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 6, 2003 Received: January 8, 2003
Dear Ms. Smith:
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.
2
Page 2 - Ms. Smith
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.
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Roane
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. Indications for Use Statement
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K030069 |
| DEVICE NAME: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| INDICATIONS: | Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation |
| System devices (Plates, Meshes, Sheets, and Screws) are | |
| intended for use in fracture repair and reconstructive procedures | |
| of the craniofacial skeleton. In addition, Resorbable Meshes, | |
| Sheets and Screws may be used in non-load bearing applications | |
| for maintaining the relative position of and/or containing bony | |
| fragments, bone grafts (autograft or allograft) or bone graft | |
| substitutes in reconstruction of the craniofacial or mandibular | |
| areas. | |
| CONTRAINDICATIONS: | These devices are not intended for use in full load bearing |
| applications, such as the mandible, unless used in conjunction | |
| with traditional rigid fixation. Synthes Poly (L-Lactide-co- | |
| Glycolide) Resorbable Fixation System devices are not intended | |
| for areas with active or latent infection or for patient conditions | |
| including limited blood supply or insufficient quantity or quality | |
| of bone. These devices are not intended for use in the spine. | |
| (PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON | |
| ANOTHER PAGE IF NEEDED) |
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ---------------------- |
| Synthes (USA)
Premarket Notification 510(k)
| PLLA/PGA Resorbable Fixation System | CONFIDENTIAL | Ren Muly (Division Sign-Off) for MSA Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K030069 |
|---|---|---|
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