(289 days)
Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes.
The provided FDA 510(k) summary does not describe an AI/ML device. Instead, it concerns a medical device called "Montage-XT Settable, Resorbable Bone Putty." Therefore, the requested information pertaining to acceptance criteria and studies demonstrating AI device performance (such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.
The document discusses the substantial equivalence of Montage-XT to a predicate device (Montage Settable, Resorbable Bone Putty) based on non-AI performance testing. Here's a breakdown of the relevant information provided:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
Given that this is not an AI device, there are no specific "acceptance criteria" in terms of algorithm performance metrics (e.g., sensitivity, specificity, AUC). Instead, the performance is evaluated through bench testing, biocompatibility testing, and animal testing to demonstrate substantial equivalence to a predicate device.
Table of Performance Comparisons for Substantial Equivalence:
| Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Montage-XT) |
|---|---|---|
| Indications for Use | To fill bony voids or gaps in the skeletal system (extremities and pelvis); surgically created or traumatic osseous defects. Not for defects intrinsic to bony structure integrity. Can augment provisional hardware and support bone fragments during surgery (temporary support). Can be drilled and tapped; hardware placed through it at any time during setting. | Identical to predicate device (Montage). This submission adds "bone void filler device" indication to Montage-XT, aligning it with Montage. |
| Formulation | Sterile, biocompatible, resorbable material (granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol, lactide-diester and polyester-based polymers). Two separate components. | Nearly identical. The document states that the devices have "nearly identical formulations" and Montage-XT contains the same components as Montage described in the device description. |
| Application Method | Manually applied and spread onto bone defects. Putty-like material at application. | Identical. Manually applied and spread onto bone defects. Putty-like material at application. |
| Setting Mechanism | Two-part putty/putty device that forms a "settable" (hardening) material when mixed at the time of surgery. Primarily comprised of calcium phosphate similar to native bone. | Identical. Same setting mechanism and primary composition. |
| Resorption Time | Implanted device is resorbable in greater than 30 days primarily due to presence of calcium phosphate. | Identical. Resorbable in greater than 30 days. Animal study data showed approximately 70% implant material remaining at 12 weeks for both Montage-XT and Montage. |
| Degradation | Non-calcium salt and non-polymeric components degrade via dissolution; polymer degrades via hydrolysis; calcium salts degrade via chemical dissolution and/or cellular removal. | Identical degradation mechanisms. |
| Sterilization | Sterile by gamma irradiation. | Identical. Sterilized by the same validated gamma irradiation process. |
| Packaging | Two putties separately within a single outer foil pouch, with a desiccant. | Identical. Same packaging. |
| Mixing for Homogeneity | 45 seconds. | Identical. 45 seconds. |
| Working Time | 2 minutes (for Montage). | 4 minutes (for Montage-XT). This is identified as the only clinically meaningful difference. |
| Exothermic Reaction | Cures with no appreciable exothermic reaction. | Identical. Cures with no appreciable exothermic reaction. |
| Drillability/Tappability | Can be drilled and tapped; hardware can be placed through it at any time during setting process. | Identical. Can be drilled and tapped; hardware can be placed through it at any time during setting process. |
| New Bone Formation | Adequate new bone formation to demonstrate efficacy as a bone void filler (implied by predicate clearance). | 20.4% new bone formation in Montage-XT group at 12 weeks, compared to 20.8% in Montage predicate group, and |
§ 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.