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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Resorb-X G Resorbable Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria with quantifiable metrics like sensitivity, specificity, or accuracy which are common for AI/ML device performance studies.

Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and statistical study designs are not directly applicable or available in this document. The information provided heavily emphasizes the technological characteristics and intended use for demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as typically seen for AI/ML device performance (e.g., minimum sensitivity, specificity). Instead, it relies on demonstrating similar performance or conformance to standards for chemical analysis, cytotoxicity, and mechanical degradation compared to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Chemical Analysis (ISO 10993-18)	Conformance to the standard tested.
Cytotoxicity (ISO 10993-5)	Conformance to the standard tested.
Mechanical Degradation Comparison (Resorb-X G vs. Resorb X (K080862))	Resorb-X G showed higher tensile strength for the first 12 weeks (97% strength retention after 4 weeks, 80% after 8 weeks, 15% at conclusion). Higher viscosity for Resorb-X G was observed during the first 11 weeks. Profile for both polymers remained relatively constant.
Biocompatibility (ISO 10993-1, -5, -12, -18)	Tested to ISO 10993-1, -5, -12, -18.
Sterility	Provided Sterile (Gamma Radiation).
Chemical Safety (ISO 10993-12, -18)	Tested to ISO 10993-12, -18.
General Safety & Effectiveness (Substantial Equivalence)	Demonstrated through similarities in intended use, fundamental technology, design, and material compared to predicate devices, and performance testing results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of AI/ML algorithms evaluated on patient data. The "testing" refers to laboratory-based performance testing of the device materials.

Sample Size for Test Set: Specific sample sizes for the chemical analysis, cytotoxicity, and mechanical degradation tests are not provided. The mechanical degradation comparison mentions testing "gamma-sterilized material," implying a laboratory sample rather than a clinical patient cohort.
Data Provenance: Not applicable as the testing involves materials rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device's testing relates to established scientific methods and standards for material properties (e.g., tensile strength, chemical composition, cytotoxicity), not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI/ML models. For material testing, results are typically determined by standardized laboratory procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device that assists human readers. It is a resorbable fixation system for surgical procedures.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing described is based on established scientific and engineering standards and validated laboratory methods for material characteristics (e.g., ISO 10993 for biocompatibility, chemical analysis, cytotoxicity, and standard methods for measuring tensile strength and viscosity).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of Performance Testing (as described in the document):

The performance testing focused on demonstrating the material properties and safety of Resorb-X G.

Chemical Analysis (ISO 10993-18) and Cytotoxicity (ISO 10993-5): Conformance to these recognized standards was reported. These tests assess the device's chemical composition and its potential to cause harm to living cells.
Mechanical Degradation Comparison: A comparative test was performed between Resorb-X G (PLLA/PGA) and Resorb X (PDLLA, from K080862) to evaluate tensile strength and viscosity over 22 weeks for gamma-sterilized material.
- Resorb-X G: Showed higher tensile strength for the first 12 weeks, with 97% strength retention after 4 weeks, 80% after 8 weeks, and 15% at the conclusion of the test (22 weeks).
- Resorb-X (PDLLA): Showed higher tensile strength in the later weeks due to a lower resorption rate.
- Viscosity: Resorb-X G showed higher viscosity for the first 11 weeks, while Resorb-X showed higher viscosity for the last 11 weeks. Both profiles remained relatively constant.

The conclusion drawn from this testing is that Resorb-X G's performance results and technological characteristics demonstrate substantial equivalence to predicate devices and do not raise new issues of safety or effectiveness.

Summary

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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 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:

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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-MXBioabsorbable BoneFixation System(K073006)	Synthes (USA) RapidResorbable FixationSystem(K062789)	Lactosorb Trauma Plating System(K992355)	Resorb-X G(K112064)	SonicWeld RX (Resorb-X)(K080862)
Resorb-X G is intendedfor use in non-loadbearing fracture repairand reconstructiveprocedures in pediatricadult populations. Inaddition, resorbablemeshes, plates and pinsmay be used in non-loadbearing applications formaintaining the relativeposition of, and/orcontaining, bonyfragments, bone grafts(autograft or allograft), orbone graft substitutes inoral and maxillofacialreconstruction.	The OSTEOTRANSTM-MXBioabsorbable BoneFixation System is intendedfor use in trauma andreconstructive procedures ofthe craniofacial skeleton,including fracture of thecranium, infant craniofacialsurgery (i.e. cranioynostosis,congenital malformations),pediatric reconstructiveprocedures, reconstructiveprocedures of the cranium,craniotomy flap fixation.	The Synthes (USA) RapidResorbable FixationSystem is intended for usein fracture repair andreconstructive proceduresof the craniofacial skeletonin pediatric and adultpopulations. In addition,resorbable meshes, sheets,screws and tacks may beused in non-load bearingapplications formaintaining the relativeposition of, and/orcontaining, bonyfragments, bone grafts,(autograft or allograft), orbone graft substitutes inreconstruction of thecraniofacial or mandibularareas.	A. General Indication: traumaprocedures of the midface orcraniofacial skeleton.Specific Indications:1. comminuted fractures of thenaso-ethmoidal and intraorbital area.2. comminuted fractures of thefrontal sinus wall.3. pediatric midface orcraniofacial 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 craniofacialskeleton, including frontal, parietal,temporal, sphenoid, and occipitalbones.B. General Indications:reconstructive procedures of themidface or craniofacial skeleton.Specific Indications:1. infant craniofacial surgery(i.e. craniosynostosis, congenitalmalformation, trauma, etc.)2. LeFort (I, II, III) osteotomies.3. tumor reconstruction in midfaceor craniofacial procedures.4. bone graft procedures in themidface or craniofacial skeleton.5. pediatric reconstructiveprocedures.6. reconstructive procedures of thecraniofacial skeleton including,frontal, parietal, temporal, sphenoid,and occipital bones.7. craniotomy flap fixation.	The KLS MartinResorb-X G is intendedfor use in non-loadbearing fracture repairand reconstructiveprocedures inadolescent and adultpopulations. Inaddition, resorbablemeshes, plates and pinsmay be used in non-load bearingapplications formaintaining the relativeposition of, and/orcontaining, bonyfragments, bone grafts(autograft or allograft),or bone graft substitutesin oral andmaxillofacialreconstruction.	The KLS Martin SonicWeldRX (Resorb-X) is intendedfor use in fracture repair andreconstructive procedures ofthe craniofacial skeleton inpediatric and adultpopulations. In addition,resorbable meshes, platesand pins may be used innon-load bearingapplications for maintainingthe relative position of,and/or containing, bonyfragments, bone grafts(autograft or allograft), orbone graft substitutes in oraland maxillofacialreconstruction.The device is not intendedfor load bearing indicationsunless used in conjunctionwith traditional rigidfixation. The KLS MartinSonicWeld RX (Resorb-X)is not intended for areaswith active or latentinfection or for patientconditions including limitedblood supply or insufficientquantity or quality of bone.These devices are notintended for use in the spine.The SonicWeld Rx pins aredesigned only to be insertedwith the Sonic Weld RxSonotrode device.
	Resorb-X G(Subject Device)	OSTEOTRANS-MXBioabsorbable BoneFixation System(K073006)	Synthes (USA) RapidResorbable FixationSystem(K062789)	Lactosorb Trauma PlatingSystem(K992355)	Resorb-X G(K112064)	SonicWeld RX (Resorb-X)(K080862)
Contraindications	• High-load regions in theabsence of traditionalrigid fixation• Active or latentinfections• Patients in a bad generalstate of health orsuffering from metabolicdisorders (such asdiabetes)	• Insufficient quality andquantity of bone forattachment of graft.• Blood supply limitationand/or previous infections,which could retard healing.• Patients with activeinfection.• Conditions, which tend tolimit the patient's ability orwillingness to restrictactivities or followdirections during the healingand rehabilitation period.	These devices are notintended for use in loadbearing applications, such asthe mandible, unless used inconjunction with traditionalrigid fixation. The SynthesRapid Resorbable System isnot intended for areas withactive or latent infection orfor patient conditionsincluding limited bloodsupply or insufficientquantity or quality of bone.These devices are notintended for use in the spine.	• Active infection.• Patient conditions including,blood supply limitations,insufficient quantity or quality ofbone stock or latent infection.• DO NOT USE in full load bearingprocedures.• DO NOT USE in thetemporomandibular joint (TMJ).	• High-load regions inthe absence oftraditional rigid fixation• Active or latentinfections• Patients in a badgeneral state of healthor suffering frommetabolic disorders(such as diabetes)	The device is not intendedfor load bearing indicationsunless used in conjunctionwith traditional rigidfixation. The KLS MartinSonic Weld RX (Resorb-X)is not intended for areaswith active or latentinfection or for patientconditions including limitedblood supply or insufficientquantity or quality of bone.These devices are notintended 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,-18ISO 11137-2, 11737-1,-2	Unknown	Unknown	Unknown	Same as currentsubmission	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 (GammaRadiation)	Provided sterile	Provided Sterile	Provided Sterile (ETO)	Provided Sterile(Gamma Radiation)	Provided Sterile (GammaRadiation)
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
BreakdownProducts	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/MeshThickness	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 MeshDimensions	126 x 126 x 1.0 mm	50 x 50 x 1.0 mm	150 x 150 x 0.8 mm	100 x 100 x 0.5 mm	126 x 126 x 1.0 mm	126 x 126 x 1.0 mm

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P.O. Box 16369 • Jacksonville, FL 32245-6369
904-641-7746 or 800-625-1557 • Fax 904-641-7378
www.klsmartin.com

kts markin L.P.

Device Comparison Table (Continued)

Resorb-X G, K121606

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kls martin LP

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.kIsmartin.com

Similarities to Predicates

Resorb-X G has the same intended use and fundamental technology as the predicate devices. Resorb-X G is identical in design to the components included in K080862 and identical in material to the Resorb-X G components cleared in K112064 and to the Synthes Rapid Resorbable Fixation System.

Differences to Predicates

Resorb-X G utilizes the previously cleared SonicWelder RX (K080862) for pin fixation. The OSTEOTRANS-MX System, Synthes Rapid Resorbable Fixation System, and LactoSorb Trauma Plating System utilize screw-type fixation.

Performance Testing:

Chemical analysis to ISO 10993-18 and cytotoxicity tests to ISO 10993-5 showed conformance to the standards tested. Mechanical degradation comparison testing between Resorb-X G and Resorb X (K080862) was performed on gamma-sterilized material over a period of 22 weeks. Results show higher tensile strength for Resorb-X G for the first 12 weeks, during which time bone consolidation would occur. A higher tensile strength for Resorb-X was observed in the following weeks, as the resorption rate for PDLLA is lower than that for PLLA-PGA. The results for Resorb-X G show 97% strength retention after 4 weeks, 80% after 8 weeks, and 15% strength retention at the conclusion of the test. Higher viscosity for Resorb-X G was also observed during the first 11 weeks while higher viscosity for Resorb-X was observed for the last 11 weeks. The profile for both polymers remained relatively constant for the duration of the test.

Conclusion:

Performance testing results and similarities in technological characteristics demonstrate that Resorb-X G is substantially equivalent to the predicate devices and does not raise new issues of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and features the department's name around the perimeter. In the center of the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

January 17,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

KLS Martin L.P. % Ms. Jennifer Damato Director of Quality Management & Regulatory Affairs 11201 Saint Johns Industrial Pkway S Jacksonville, FL 32246

Re: K121606

Trade/Device Name: Resorb-X G Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, HBW Dated: December 26, 2012 Received: January 4, 2013

Dear Ms. Damato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosary to regars) to regard to the Medical Device Amendments, or to commerce provision of they 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in assee approval of a premarket approval application (PMA). and Cosmetic Act (710c) that to not required to the general controls provisions of the Act. The I ou may, incretore, manel the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. I loase noter of the ever, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elassified (600 a00 ro). Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that 1 DX has intact a down regulations administered by other Federal agencies. You must or any I cuthar statures and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Jennifer Damato

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific aar/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou thay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K121606 510(k) Number (if known): J

Device Name: _

Resorb-X G

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 prooduled in poularly and bearing applications for maintaining the relative ana pino of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in cranial reconstruction.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M.Whang

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K121606

Page 1 of 1

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
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.(b)
Classification. Class II (performance standards).