(48 days)
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be tysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
The subject devices are a magnesium-based synthetic bone void filler that is moldable, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
The provided text is a Medical Device 510(k) Premarket Notification from the FDA. It does not describe acceptance criteria or a study that proves the device meets those criteria. Instead, it is a notification letter and a "510(k) Summary" which highlights the device's intended use, classification, comparison to predicate devices, and performance data summary.
Specifically, the "PERFORMANCE DATA" section states: "No clinical data were included in this submission." This indicates that there was no clinical study performed to demonstrate the device meets acceptance criteria in a human clinical setting. The submission primarily relies on non-clinical testing and leveraging data from previously cleared predicate and reference devices to demonstrate substantial equivalence.
Therefore, I cannot provide the requested information from the given text because the information regarding acceptance criteria and a study to prove the device meets these criteria (especially in a clinical context with human subjects/data) is explicitly stated as not included in this submission.
The document discusses:
- Non-clinical testing data referenced from other K numbers (K212991, K071004) for aspects like chemical composition, physical properties, sterilization, shelf life, biocompatibility, drillability, and use as an adjunct to hardware fixation.
- Bacterial endotoxin testing (LAL test) meeting a specified limit, again demonstrating a non-clinical performance aspect.
- Comparison to predicate devices to establish substantial equivalence.
It does not describe:
- Acceptance criteria for clinical performance (e.g., success rates in healing, pain reduction, etc.).
- A clinical study with human subjects, patient data, ground truth establishment by experts, or MRMC studies.
Without such information in the provided text, I cannot generate the table or answer the specific questions about clinical study design and results.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.