(197 days)
No
The device description and intended use focus on mechanical components for bone distraction and lengthening, with no mention of AI or ML capabilities.
Yes
The device is described as "intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible." This indicates a therapeutic intended use.
No
Explanation: The device is described as a surgical instrument (stabilizer and lengthener of the mandible) used in the treatment of conditions, not for diagnosing them.
No
The device description clearly states it is comprised of physical components made of stainless steel (arms, central body, screws, pin clamps), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical treatment of bone conditions. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a mechanical implant made of stainless steel, designed to be surgically implanted to stabilize and lengthen bone. This is consistent with a surgical device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components and functions of IVDs.
Therefore, the Mandibular Bone Distractor II is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mandibular Bone Distractor II is intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible. This device is intended to function as a stabilizer and mandibular lengthener. Bone transport procedures may also be performed. This device will allow linear and angular distraction of the mandible.
Product codes
OR(87) JEC
Device Description
The Mandibular Bone Distractor II is comprised of two arms, a central body which contains screws to adjust the angular relationship of the arms, and pin clamps. The pin clamps can accept 2mm or 3mm pins.
All of the components of the Mandibular Bone Lengthener II are fabricated from stainless steel.
The Mandibular Bone Distractor II is intended to be sold nonsterile. Sterilization instructions are included in the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible
Indicated Patient Age Range
adults or children
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)
Reference Device(s)
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
510 (k) Summary
Mandibular Bone Distractor II Device:
Common Name: External Fixation for Mandible
Classification Name and Reference: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener
Proposed Regulatory Class: Class II
Device Product Code: OR(87) JEC મવામ
For information contact: Marqaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507- 7431 Fax: (201) 507-6870
The Mandibular Bone Distractor II is intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible. This device is intended to function as a stabilizer and mandibular lengthener. Bone transport procedures may also be performed. This device will allow linear and angular distraction of the mandible. The Mandibular Bone Distractor is intended for use in either adults or children.
The Mandibular Bone Distractor II is comprised of two arms, a central body which contains screws to adjust the angular relationship of the arms, and pin clamps. The pin clamps can accept 2mm or 3mm pins.
All of the components of the Mandibular Bone Lengthener II are fabricated from stainless steel.
The Mandibular Bone Distractor II is intended to be sold nonsterile. Sterilization instructions are included in the labeling.
1
The Mandibular Bone Distractor II is substantially equivalent to products currently in commercial distribution. A list of these equivalent products may be found below.
- Mandibular Bone Distractor Howmedica (K945674) 1.
- Hoffman Mini Fixator Howmedica (K792561) 2.
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- Monticelli-Spinelli External Fixator - Howmedica (K864403)
- Mini Lengthening Apparatus Synthes (K914558) 4 .
- Normed Device distributed in the United States by Ace 5. Surgical Supply Co. (K# unknown)
- Wells Johnson Fixation System Wells Johnson Co. ୧. (K945500)
The Mandibular Bone Distractor II is similar to the named devices and operational with respect to intended use, material, design, principles as discussed below:
- All of the named devices, and the Mandibular 1. Intended Use: Bone Lengthener II, are intended to be used as external fixation devices for the stabilization of bone and bone The Mandibular Bone Lengthener, Synthes device, fragments. Monticelli-Spinelli device, and the subject device are designed to allow distraction of bone segments to achieve The Monticelli-Spinelli device, the Normed lengthening. device, the Wells Johnson device, and the Mandibular Bone Distractor II allow anqular distraction. The Synthes Mini-Lengthener, the Normed device, the Mandibular Bone Distractor, the Wells Johnson device, and the Mandibular Bone Distractor II are specifically intended to be used in mandibular applications.
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- The materials used in the manufacture of the Material: Mandibular Bone Lengthener II are different grades of stainless steel. Stainless steel has a long history of successful clinical usage. Stainless steel is used in the manufacture of the Hoffman Mini Fixator, Synthes Mini-Lengthener, and the Mandibular Bone Lengthener.
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- Design: The basic design features of the Mandibular Bone Distractor II, namely, pin clamps that are attached to connecting rods that are adjusted in relation to each other, are the same for all of the named systems. More detailed design features are discussed below:
- Pin clamp: The Mandibular Bone Distractor II, the a) Hoffman Mini device, and the Wells Johnson device offer pin clamps that accept either 2mm or 3mm pin.
- b) Threaded arms: The Mandibular Bone Distractor II, the Normed device, and the Synthes Mini-Lengthener have arms, or connecting rods that are threaded to accept a pin clamp.
2
- Screw Mechanism: The Mandibular Bone Distractor II, C) the Mandibular Bone Distractor, the Synthes Mini Lengthener, the Normed device, and the Monticelli-Spinelli device all have screw mechanisms that the surgeon adjusts to control either the relationship of one pin clamp to another, or the relationship of one connecting rod (or arm) to another.
- Operational Principles: The basic operational principles 4 . for the Hoffman Mini-Fixator, Synthes Mini Lengthener, the Mandibular Bone Distractor, Normed device, the Wells Johnson device and the subject device are similar - namely site preparation, pin placement, and device construction. The bone distraction procedure is similar for the Mandibular Bone Distractor II, the Synthes Mini-Lengthener, the Normed device, the Wells Johnson device, and the existing Mandibular Bone Distractor.