Who is the manufacturer of RESORB-X G?

KLS-Martin L.P. filed the 510(k) submission for RESORB-X G (K121606).

What is the FDA product code for RESORB-X G?

GWO. It is classified under 21 CFR 882.5320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for RESORB-X G?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RESORB-X G?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESORB-X G

Q: What are the predicate devices for RESORB-X G?

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

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

Indications for 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)

{0}------------------------------------------------ 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 904-641-7378 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: 800-625-1557 Fax: 904-641-7378 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. {1}------------------------------------------------ kts markın t.p. P.O. Box 16369 • Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartin.com # echnological Characteristics/Substantial Equivalence # Device Comparison Tabl | Resorb-X G (Subject Device) | OSTEOTRANS-MX Bioabsorbable Bone Fixation System (K073006) | Synthes (USA) Rapid Resorbable Fixation System (K062789) | Lactosorb Trauma Plating System (K992355) | Resorb-X G (K112064) | SonicWeld RX (Resorb-X) (K080862) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Resorb-X G is intended for use in non-load bearing fracture repairand reconstructive procedures in pediatric 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 oral and maxillofacial reconstruction. | The OSTEOTRANSTM-MX Bioabsorbable Bone Fixation System is intended for use in trauma and reconstructive procedures of the craniofacial skeleton, including fracture of the cranium, infant craniofacial surgery (i.e. cranioynostosis, congenital malformations), pediatric reconstructive procedures, reconstructive procedures of the cranium, craniotomy flap fixation. | The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks 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 reconstruction of the craniofacial or mandibular areas. | A. General Indication: trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1. comminuted fractures of the naso-ethmoidal and intraorbital area. 2. comminuted fractures of the frontal sinus wall. 3. pediatric midface or craniofacial trauma. 4. LeFort (I, II, III) fractures. 5. orbital floor fractures. 6. fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7. trauma of the craniofacial skeleton, including frontal, parietal, temporal, sphenoid, and occipital bones. B. General Indications: reconstructive procedures of the midface or craniofacial skeleton. Specific Indications: 1. infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.) 2. LeFort (I, II, III) osteotomies. 3. tumor reconstruction in midface or craniofacial procedures. 4. bone graft procedures in the midface or craniofacial skeleton. 5. pediatric reconstructive procedures. 6. reconstructive procedures of the craniofacial skeleton including, frontal, parietal, temporal, sphenoid, and occipital bones. 7. craniotomy flap fixation. | The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent 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 oral and maxillofacial reconstruction. | The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton 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 oral and maxillofacial reconstruction. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. The SonicWeld Rx pins are designed only to be inserted with the Sonic Weld Rx Sonotrode device. | | | | Resorb-X G (Subject Device) | OSTEOTRANS-MX Bioabsorbable Bone Fixation System (K073006) | Synthes (USA) Rapid Resorbable Fixation System (K062789) | Lactosorb Trauma Plating System (K992355) | Resorb-X G (K112064) | SonicWeld RX (Resorb-X) (K080862) | | Contraindications | • High-load regions in the absence of traditional rigid fixation • Active or latent infections • Patients in a bad general state of health or suffering from metabolic disorders (such as diabetes) | • Insufficient quality and quantity of bone for attachment of graft. • Blood supply limitation and/or previous infections, which could retard healing. • Patients with active infection. • Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period. | These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The Synthes Rapid Resorbable System is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. | • Active infection. • Patient conditions including, blood supply limitations, insufficient quantity or quality of bone stock or latent infection. • DO NOT USE in full load bearing procedures. • DO NOT USE in the temporomandibular joint (TMJ). | • High-load regions in the absence of traditional rigid fixation • Active or latent infections • Patients in a bad general state of health or suffering from metabolic disorders (such as diabetes) | The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin Sonic Weld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not 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 ISO 11137-2, 11737-1,-2 | Unknown | Unknown | Unknown | Same as current 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, -5,-12,-18 | Unknown | Unknown | Unknown | Tested to ISO 10993-1, -5,-12,-18 | ISO 10993 | | Sterility | Provided Sterile (Gamma Radiation) | Provided sterile | Provided Sterile | Provided Sterile (ETO) | Provided Sterile (Gamma Radiation) | Provided Sterile (Gamma Radiation) | | Where used (hospital, home, etc) | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | | Chemical Safety | Tested to ISO 10993-12, -18 | H₂O, CO₂, Ca, PO₄ | Unknown | Unknown | Tested to ISO 10993- 12,-18 | ISO 10993 | | Breakdown 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 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 Dimensions…

RESORB-X G

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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RESORB-X G

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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