RESORB-X G

K121606 · KLS-Martin L.P. · GWO · Jan 17, 2013 · Neurology

Device Facts

• Record ID: K121606
• Device Name: RESORB-X G
• Applicant: KLS-Martin L.P.
• Product Code: GWO · Neurology
• Decision Date: Jan 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in cranial reconstruction.

Device Story

Resorb-X G consists of resorbable plates, meshes, and pins (PLLA/PGA material) for fixation, alignment, and stabilization of cranial fractures and reconstructive procedures. Device is used in hospitals by surgeons. Pins are inserted using the SonicWeld RX ultrasonic unit; ultrasonic energy causes phase transition in the pin, allowing it to adapt to drilled pilot holes and utilize bone micro-undercuts for retention. Output is a stabilized bone construct. Benefits include bioresorbable fixation, eliminating need for secondary removal surgery. Device is not for load-bearing applications unless supplemented by traditional rigid fixation.

Clinical Evidence

Bench testing only. Chemical analysis (ISO 10993-18) and cytotoxicity (ISO 10993-5) confirmed conformance. Mechanical degradation testing compared Resorb-X G to Resorb-X (K080862) over 22 weeks; Resorb-X G showed 97% strength retention at 4 weeks, 80% at 8 weeks, and 15% at 22 weeks. Viscosity profiles remained relatively constant.

Technological Characteristics

Materials: PLLA/PGA copolymer. Sensing/Actuation: Ultrasonic energy (via SonicWeld RX unit) for pin phase transition/fixation. Form factor: Plates, meshes, pins of various sizes. Sterilization: Gamma radiation. Connectivity: None. Software: None.

Indications for Use

Indicated for non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations, including maintaining position of bony fragments, bone grafts, or bone graft substitutes in cranial reconstruction. Contraindicated in high-load regions without traditional rigid fixation, active/latent infections, and patients with poor health or metabolic disorders (e.g., diabetes).

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• OSTEOTRANS™-MX (K073006)
• Resorb-X G (K112064)
• Synthes Rapid Resorbable Fixation System (K062789)
• LactoSorb Trauma Plating System (K992355)
• SonicWeld RX (Resorb-X) (K080862)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "KLS martin L.P.". The words "KLS" and "L.P." are in bold black font. The word "martin" is in a white font with a black outline.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax [phone] www.klsmartin.com

**510(k) Summary**
Section 21 CFR 807.92

K121606

Submitter:

KLS Martin, L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville. FL 32246

JAN 1 7 2013

Contact Person:

Jennifer Damato Director of Quality Mgt and Regulatory Affairs Phone: [phone] Fax: [phone]

Date Prepared:

Trade Name:

Resorb-X G

December 31, 2012

Resorbable Fixation System

Common Name:

Classification:

Preformed alterable cranioplasty plate Class II, 21 CFR 882.5320, Product Code GWO

Cranioplasty plate fastener Class II, 21 CFR 882.5360, Product Code HBW

Predicate Devices:

OSTEOTRANS™-MX (K073006) Resorb-X G (K112064) Synthes Rapid Resorbable Fixation System (K062789) LactoSorb Trauma Plating System (K992355) SonicWeld RX (Resorb-X) (K080862)

### Device Description:

The Resorb-X G product line consists of plates, meshes and pins manufactured in a variety of sizes and configurations to provide fixation and aid in the alignment and stabilization of fractures in reconstructive procedures. Resorb-X G is implanted using ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention.

The plate, mesh and pin sizes and configurations are identical to components previously cleared in K080862, Sonic Weld RX (Resorb-X). The PLLA/PGA material is identical to that cleared in K 12064, Resorb-X G. This premarket notification is being submitted to expand the indications for use for Resorb-X G to include cranial use in pediatric and adult populations and includes additional sizes and configurations in the PLLA/PGA material for cranial use.

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kts markın t.p.

P.O. Box 16369 • Jacksonville, FL 32245-6369
904-641-7746 or 800-625-1557 • Fax [phone]
www.klsmartin.com

# echnological Characteristics/Substantial Equivalence

# Device Comparison Tabl

| Resorb-X G<br>(Subject Device) | OSTEOTRANS-MX<br>Bioabsorbable Bone<br>Fixation System<br>(K073006) | Synthes (USA) Rapid<br>Resorbable Fixation<br>System<br>(K062789) | Lactosorb Trauma Plating System<br>(K992355) | Resorb-X G<br>(K112064) | SonicWeld RX (Resorb-X)<br>(K080862) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resorb-X G is intended<br>for use in non-load<br>bearing fracture repairand reconstructive<br>procedures in pediatric<br>adult populations. In<br>addition, resorbable<br>meshes, plates and pins<br>may be used in non-load<br>bearing applications for<br>maintaining the relative<br>position of, and/or<br>containing, bony<br>fragments, bone grafts<br>(autograft or allograft), or<br>bone graft substitutes in<br>oral and maxillofacial<br>reconstruction. | The OSTEOTRANSTM-MX<br>Bioabsorbable Bone<br>Fixation System is intended<br>for use in trauma and<br>reconstructive procedures of<br>the craniofacial skeleton,<br>including fracture of the<br>cranium, infant craniofacial<br>surgery (i.e. cranioynostosis,<br>congenital malformations),<br>pediatric reconstructive<br>procedures, reconstructive<br>procedures of the cranium,<br>craniotomy flap fixation. | The Synthes (USA) Rapid<br>Resorbable Fixation<br>System is intended for use<br>in fracture repair and<br>reconstructive procedures<br>of the craniofacial skeleton<br>in pediatric and adult<br>populations. In addition,<br>resorbable meshes, sheets,<br>screws and tacks may be<br>used in non-load bearing<br>applications for<br>maintaining the relative<br>position of, and/or<br>containing, bony<br>fragments, bone grafts,<br>(autograft or allograft), or<br>bone graft substitutes in<br>reconstruction of the<br>craniofacial or mandibular<br>areas. | A. General Indication: trauma<br>procedures of the midface or<br>craniofacial skeleton.<br>Specific Indications:<br>1. comminuted fractures of the<br>naso-ethmoidal and intraorbital area.<br>2. comminuted fractures of the<br>frontal sinus wall.<br>3. pediatric midface or<br>craniofacial trauma.<br>4. LeFort (I, II, III) fractures.<br>5. orbital floor fractures.<br>6. fractures of the maxilla,<br>zygoma, zygomatic arch, orbital rim,<br>nasal, ethmoid, and lacrimal bones.<br>7. trauma of the craniofacial<br>skeleton, including frontal, parietal,<br>temporal, sphenoid, and occipital<br>bones.<br>B. General Indications:<br>reconstructive procedures of the<br>midface or craniofacial skeleton.<br>Specific Indications:<br>1. infant craniofacial surgery<br>(i.e. craniosynostosis, congenital<br>malformation, trauma, etc.)<br>2. LeFort (I, II, III) osteotomies.<br>3. tumor reconstruction in midface<br>or craniofacial procedures.<br>4. bone graft procedures in the<br>midface or craniofacial skeleton.<br>5. pediatric reconstructive<br>procedures.<br>6. reconstructive procedures of the<br>craniofacial skeleton including,<br>frontal, parietal, temporal, sphenoid,<br>and occipital bones.<br>7. craniotomy flap fixation. | The KLS Martin<br>Resorb-X G is intended<br>for use in non-load<br>bearing fracture repair<br>and reconstructive<br>procedures in<br>adolescent and adult<br>populations. In<br>addition, resorbable<br>meshes, plates and pins<br>may be used in non-<br>load bearing<br>applications for<br>maintaining the relative<br>position of, and/or<br>containing, bony<br>fragments, bone grafts<br>(autograft or allograft),<br>or bone graft substitutes<br>in oral and<br>maxillofacial<br>reconstruction. | The KLS Martin SonicWeld<br>RX (Resorb-X) is intended<br>for use in fracture repair and<br>reconstructive procedures of<br>the craniofacial skeleton in<br>pediatric and adult<br>populations. In addition,<br>resorbable meshes, plates<br>and pins may be used in<br>non-load bearing<br>applications for maintaining<br>the relative position of,<br>and/or containing, bony<br>fragments, bone grafts<br>(autograft or allograft), or<br>bone graft substitutes in oral<br>and maxillofacial<br>reconstruction.<br><br>The device is not intended<br>for load bearing indications<br>unless used in conjunction<br>with traditional rigid<br>fixation. The KLS Martin<br>SonicWeld RX (Resorb-X)<br>is not intended for areas<br>with active or latent<br>infection or for patient<br>conditions including limited<br>blood supply or insufficient<br>quantity or quality of bone.<br>These devices are not<br>intended for use in the spine.<br><br>The SonicWeld Rx pins are<br>designed only to be inserted<br>with the Sonic Weld Rx<br>Sonotrode device. | |
| | Resorb-X G<br>(Subject Device) | OSTEOTRANS-MX<br>Bioabsorbable Bone<br>Fixation System<br>(K073006) | Synthes (USA) Rapid<br>Resorbable Fixation<br>System<br>(K062789) | Lactosorb Trauma Plating<br>System<br>(K992355) | Resorb-X G<br>(K112064) | SonicWeld RX (Resorb-X)<br>(K080862) |
| Contraindications | • High-load regions in the<br>absence of traditional<br>rigid fixation<br>• Active or latent<br>infections<br>• Patients in a bad general<br>state of health or<br>suffering from metabolic<br>disorders (such as<br>diabetes) | • Insufficient quality and<br>quantity of bone for<br>attachment of graft.<br>• Blood supply limitation<br>and/or previous infections,<br>which could retard healing.<br>• Patients with active<br>infection.<br>• Conditions, which tend to<br>limit the patient's ability or<br>willingness to restrict<br>activities or follow<br>directions during the healing<br>and rehabilitation period. | These devices are not<br>intended for use in load<br>bearing applications, such as<br>the mandible, unless used in<br>conjunction with traditional<br>rigid fixation. The Synthes<br>Rapid Resorbable System is<br>not intended for areas with<br>active or latent infection or<br>for patient conditions<br>including limited blood<br>supply or insufficient<br>quantity or quality of bone.<br>These devices are not<br>intended for use in the spine. | • Active infection.<br>• Patient conditions including,<br>blood supply limitations,<br>insufficient quantity or quality of<br>bone stock or latent infection.<br>• DO NOT USE in full load bearing<br>procedures.<br>• DO NOT USE in the<br>temporomandibular joint (TMJ). | • High-load regions in<br>the absence of<br>traditional rigid fixation<br>• Active or latent<br>infections<br>• Patients in a bad<br>general state of health<br>or suffering from<br>metabolic disorders<br>(such as diabetes) | The device is not intended<br>for load bearing indications<br>unless used in conjunction<br>with traditional rigid<br>fixation. The KLS Martin<br>Sonic Weld RX (Resorb-X)<br>is not intended for areas<br>with active or latent<br>infection or for patient<br>conditions including limited<br>blood supply or insufficient<br>quantity or quality of bone.<br>These devices are not<br>intended for use in the spine. |
| Target Population | Adults & Pediatrics | Adults & Pediatrics | Adults & Pediatrics | Adults & Pediatrics | Adults & Adolecents | Adults & Pediatrics |
| Anatomical Sites | Cranial | Craniofacial | Craniofacial | Craniofacial | Oral & Maxillofacial | Craniofacial |
| Standards Met | ISO 10993-1,-5,-12,-18<br>ISO 11137-2, 11737-1,-2 | Unknown | Unknown | Unknown | Same as current<br>submission | Same as current submission |
| Materials | 85% PLLA, 15% PGA | 30-40% u-HA, PLLA | 85% PLLA, 15% PGA | 82% PLLA, 18% PGA | 85% PLLA, 15% PGA | PDLLA |
| Biocompatibility | Tested to ISO 10993-1,<br>-5,-12,-18 | Unknown | Unknown | Unknown | Tested to ISO 10993-1,<br>-5,-12,-18 | ISO 10993 |
| Sterility | Provided Sterile (Gamma<br>Radiation) | Provided sterile | Provided Sterile | Provided Sterile (ETO) | Provided Sterile<br>(Gamma Radiation) | Provided Sterile (Gamma<br>Radiation) |
| Where used<br>(hospital, home, etc) | Health Care Facilities/<br>Hospitals | Health Care Facilities/<br>Hospitals | Health Care Facilities/<br>Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/<br>Hospitals | Health Care Facilities/<br>Hospitals |
| Chemical Safety | Tested to ISO 10993-12,<br>-18 | H₂O, CO₂, Ca, PO₄ | Unknown | Unknown | Tested to ISO 10993-<br>12,-18 | ISO 10993 |
| Breakdown<br>Products | H₂O and CO₂ | H₂O and CO₂ | H₂O and CO₂ | H₂O and CO₂ | H₂O and CO₂ | H₂O and CO₂ |
| Resorption Time | 12-14 months | 4-6 years | 12 months | 12 months | 12-14 months | 12-18 months |
| Dimensions | | | | | | |
| Plate/Mesh<br>Thickness | 0.3 - 1.0 mm | 0.7 - 1.4 mm | 0.25 - 1.2 mm | 0.25 - 1.14 mm | 0.6 - 1.0 mm | 0.1 - 2.0 mm |
| Max Mesh<br>Dimensions…