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)

Reference Devices

K080862, K 12064

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a resorbable fixation system and its material properties and mechanical performance, with no mention of AI or ML.

Therapeutic

Yes.
The device is used in non-load bearing fracture repair and reconstructive procedures, which are therapeutic medical interventions.

Diagnostic

No

Resorb-X G is described as a product line of plates, meshes, and pins designed for fixation and stabilization of fractures in reconstructive procedures. Its intended use is in non-load bearing fracture repair and reconstructive procedures. These functions are therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of physical components (plates, meshes, and pins) and is implanted using an ultrasonic unit. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "non-load bearing fracture repair and reconstructive procedures" and "maintaining the relative position of, and/or containing, bony fragments, bone grafts...in cranial reconstruction." This describes a surgical implant used directly on the patient's body.
Device Description: The description details plates, meshes, and pins made of PLLA/PGA material that are implanted using ultrasonic force. This is a physical device used in surgery.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GWO, HBW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cranial

Indicated Patient Age Range

pediatric and adult populations.

Intended User / Care Setting

Health Care Facilities/ Hospitals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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:

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:

comminuted fractures of the
naso-ethmoidal and intraorbital area.
comminuted fractures of the
frontal sinus wall.
pediatric midface or
craniofacial trauma.
LeFort (I, II, III) fractures.
orbital floor fractures.
fractures of the maxilla,
zygoma, zygomatic arch, orbital rim,
nasal, ethmoid, and lacrimal bones.
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:
infant craniofacial surgery
(i.e. craniosynostosis, congenital
malformation, trauma, etc.)
LeFort (I, II, III) osteotomies.
tumor reconstruction in midface
or craniofacial procedures.
bone graft procedures in the
midface or craniofacial skeleton.
pediatric reconstructive
procedures.
reconstructive procedures of the
craniofacial skeleton including,
frontal, parietal, temporal, sphenoid,
and occipital bones.
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.

2

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

3

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.

4

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

5

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

6

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

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