(106 days)
KLS Martin - Track 1.0 & 1.5mm System, Lorenz Surgical, Inc - Lorenz Distraction System
Not Found
No
The document describes a mechanical device for bone distraction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to lengthen bone in the alveolar ridge, addressing deficiencies caused by trauma, resorption, disease, tumor resection, and congenital deformities, which is a therapeutic intervention.
No
Explanation: The device is described as an "Alveolar Ridge Distractor" intended for "vertical bone lengthening" and "bone distraction." This is a therapeutic or surgical device, not one used for diagnosis.
No
The device description clearly outlines physical components (distractor body, transport plate, base plate, vector control mechanism, screws) that are implanted, 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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Synthes Alveolar Distractor is a surgical implant used to physically lengthen bone in the jaw. It is a mechanical device that directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly describes a surgical procedure for bone lengthening, not the analysis of biological samples.
The provided information describes a surgical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of:
- Trauma
- Resorption after dental extraction .
- Periodontal disease .
- Tumor resection ◆
- Congenital deformity .
Product codes
MQN
Device Description
The Synthes Alveolar Ridge Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge in the mandible and the maxilla
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)
KLS Martin - Track 1.0 & 1.5mm System, Lorenz Surgical, Inc - Lorenz Distraction System
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
Image /page/0/Picture/0 description: The image shows the Synthes logo and the date APR 12 2005. The Synthes logo is a circle with a stylized "S" inside. The word "SYNTHES" is written in bold, black letters next to the logo. The date is written in black letters to the right of the word "SYNTHES". A horizontal line is present below the logo and text.
.
APR 1 2 2005
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1690 Russell Road | ||
| Paoli, PA 19301 | ||
| (610) 647-9700 | ||
| Device Name: | Synthes Alveolar Ridge Distractor | |
| Classification: | Class II, §872.4760 - Bone Plate | |
| Predicate Device: | KLS Martin - Track 1.0 & 1.5mm System | |
| Lorenz Surgical, Inc - Lorenz Distraction System | ||
| Device Description: | The Synthes Alveolar Ridge Distractor is an extraosseous | |
| distraction device consisting of a distractor body, a transport plate, | ||
| a base plate, and a vector control mechanism. It is intended to be | ||
| placed submucosally, with the base plate fastened to the stationary | ||
| segment of the mandible or maxilla and the transport plate fastened | ||
| to the mobile bone segment. The plates are fixed to the bone using | ||
| 1.5 mm cortex screws. | ||
| Intended Use: | The Synthes Alveolar Distractor is intended for vertical bone | |
| lengthening of the alveolar ridge in the mandible and the maxilla | ||
| where gradual bone distraction is required, including deficiency in | ||
| bone height as a result of trauma, resorption after dental extraction, | ||
| periodontal disease, tumor resection, and congential deformity. | ||
| Substantial | ||
| Equivalence: | Documentation was provided which demonstrated the Synthes | |
| Alveolar Ridge Distractor to be substantially equivalent to other | ||
| legally marketed devices. | ||
| The term "substantial equivalence" as used in this 510(k) | ||
| notification is limited to the definition of substantial equivalence | ||
| found in the Federal Food, Drug and Cosmetic Act, as amended | ||
| and as applied under 21CFR 807, Subpart E under which a device | ||
| can be marketed without premarket approval or reclassification. A | ||
| determination of substantial equivalency under this notification is | ||
| not intended to have any bearing whatsoever on the resolution of | ||
| patent infringement suits or any other patent matters. No | ||
| statements related to, or in support of substantial equivalence | ||
| herein shall be construed as an admission against interest under the | ||
| US Patent Laws or their application by the courts. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2005
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K043555
Trade/Device Name: Synthes (USA) Alveolar Ridge Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: March 17, 2005 Received: March 18, 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 Eederal Register.
2
Page 2 - ms. Anderson
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
CluLs
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 design inside. A horizontal line is underneath the word "SYNTHES" and the logo. The logo appears to be a registered trademark symbol.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Alveolar Ridge Distractor_______________________________________________________________________________________________________________________________________
K0435555
Indications for Use:
The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of:
- . Trauma
- Resorption after dental extraction .
- Periodontal disease .
- Tumor resection ◆
- Congenital deformity .
X Prescription Use (Per 21 CFR 801.109)
AND/OR
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)
| Senior | |
|---|---|
| Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number | KA13555 |
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