(90 days)
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral micinal "itsanon" do recess" to "all bones of the hand, feet, wrist, ankles, fingers and toes, Craino-maximonomics, osteotomies, revision procedures, joint fusion and reconstructive procedures.
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up The son urining become are the we ar cross drive. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
The provided document describes a medical device, the Lorenz Self Drilling Screw, and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document primarily focuses on:
- Description of the Device: Lorenz Self Drilling Screw sizes, material, and self-drilling feature.
- Intended Use: Internal fixation for various bone stabilization and fixation procedures in specific anatomical regions (oral, cranio-maxillofacial, small bones of hand, feet, wrist, ankles, fingers, toes).
- Sterility: Marketed as non-sterile, single-use, with steam sterilization recommendations.
- Substantial Equivalence: Comparison to previously cleared devices (Synthes 1.3MM Self Drilling Screw, Osteomed Corp. Auto-Drive Bone Screw, KLS Martin L.P. Centre-Drive Drill Free Screw) to demonstrate its equivalence for regulatory purposes.
- Possible Risks: A list of potential complications associated with the device and surgical procedures.
- FDA Clearance Letter: A letter from the FDA confirming the device's substantial equivalence to predicate devices and granting marketing authorization under the Federal Food, Drug, and Cosmetic Act.
No information is provided regarding:
- Acceptance Criteria Table and Reported Device Performance: There is no mention of specific quantitative or qualitative acceptance criteria (e.g., strength, torque, biological response thresholds) that the device must meet, nor any performance data from tests.
- Study Details: There is no description of any study, clinical or non-clinical, that would assess the device's performance against predefined criteria. Therefore, details such as sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment are absent.
- Training Set Sample Size and Ground Truth: Since no study is described to evaluate the device, there is no mention of training sets or how their ground truth would be established.
The document serves as a regulatory submission (510(k)) to demonstrate substantial equivalence, which often relies on comparison to predicate devices that have already established safety and effectiveness. It does not typically require novel performance studies for the device itself unless there are significant technological differences or new indications that cannot be supported by existing predicate data.
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013954
Summary of Safety and Effectiveness
FEB 2 8 2002
Lorenz Self Drilling Screw Device Name:
Screw, Fixation, Bone Classification Name:
87HWC (21 CFR 888.3040) Device Product Code:
Intended Use:
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral micinal "itsanon" do recess" to "all bones of the hand, feet, wrist, ankles, fingers and toes, Craino-maximonomics, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Description:
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up The son urining become are the we ar cross drive. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
Sterility Information:
The Lorenz Self Drilling Screws will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.
Substantial Equivalence:
Walter Lorenz considers the Lorenz Self Drilling Screws equivalent to Synthes 1.3MM Self C Drilling Screw (K983485), Osteomed Corp. Auto-Drive Bone Screw (K974785), and KLS TAB 3 includes a substantial Martin L.P. Centre-Drive Drill Free Screw (K971297). equivalence comparison table to competitive devices. TAB 4 includes sales information and/or Premarket clearance (510K) for Synthes, Osteomed Corp. and KLS Martin L.P.
Possible risks:
-
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening of the device.
-
- Nonunion or delayed union which may lead to breakage of the implant.
-
- Migration, bending, fracture or loosening of the implant
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Decrease in bone density due to stress shielding.
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- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
-
- Increased fibrous tissue response around the fracture site and/or the implant.
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- Necrosis of bone.
-
- Inadequate healing.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K013954
Trade/Device Name: Lorenz Self Drilling Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 29, 2001 Received: November 30, 2001
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section >10(x) premail.com substantially equivalent (for the indications felerenced above and nave ucterimined in asketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manatical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Ecderal Food - Frye commerce prior to May 28, 1976, the enaomines with the provisions of the Federal Food, Drug, devices that have been recassinou in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, belyer to the many al registration, listing of general controls provisions of the 120 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 If your device is classified (500 above) into existing major regulations affecting your device can may be subject to such additional controller and the may of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchasing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a backed on the other requirements of the Act that IDA has made a dolorimizations administered by other Federal agencies. You must or ally Federal statures and regulations administration of registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as school collection in the closed CFK Fall 807), labeling (21 CFR Part 800), good that if applicable. the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if application (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Kim Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket nothication. The PDA miding of basification 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 and If you desire specific advice for your acvitro diagnostic devices), please contact the Office of additionally 21 CFN Part 607.10 for mirrate untile promotion and advertising of Compliance at (301) 594-4057. Tuditionally 10 quest 1001) 594-4639. Also, please note the your device, prease comate and of eference to premarket notifications of (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the nex Other general information on your responsibilities under the Act may be obtained from the Other general information on your respentional 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,
L. Muh A. Milkeron
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number: k(0)3954/
Device Name: Lorenz Self Drilling Screw
Indications For Use:
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral toes cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, finages and toes, cranio-maxilional skeicial bone, amall oches or and and reconstructive procedures.
(PLEASE DO 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 (Optional Format 1-2-96)
Mark H. Millman
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013954
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.