(126 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the physical components (archbars, plates, screws) used for temporary bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the temporary stabilization of mandibular and maxillary fractures, and to maintain proper occlusion during bone healing, which are therapeutic actions.
No
The device is intended for temporary stabilization of fractures and maintaining occlusion, which are treatment functions, not diagnostic ones.
No
The device description explicitly details physical components made of metallic materials (CP Titanium, Ti-6Al-4V) including archbars, sliding locking plates, and screws, along with necessary instruments for placement. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary stabilization of mandibular and maxillary fractures and maintaining proper occlusion. This is a surgical/mechanical intervention on the patient's body.
- Device Description: The device consists of metallic archbars, plates, and screws used for fixation. These are implantable or externally applied devices for structural support.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is clearly a surgical device used for the treatment of bone fractures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).
Product codes
JEY
Device Description
The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metallic archbars with sliding locking plates that attach to the dental arches with self-drilling locking screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67:2013), are available in either a 7-hole or 9-hole sliding plate configuration with two different lengths, and are 0.5 mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8 mm self-drilling locking screws manufactured from Ti-6Al-4V (ASTM F136:2013). Implants are available both sterile and non-sterile. The system also includes the necessary instruments to facilitate placement of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary fractures, maxillomandibular fixation (MMF)
Indicated Patient Age Range
adults or adolescents who have permanent teeth present (ages 12 and older).
Intended User / Care Setting
qualified and trained physicians in healthcare facilities/hoopitals.
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)
Mechanical Properties Testing: Tensile testing to demonstrate the maximum tensile strength of the L1 MMF System devices was performed and compared with the tensile strength of the Synthes MatrixWAVE MMF System (K141165). Results of the testing show the subject device system has an equal or greater tensile force than the predicate device, therefore demonstrating substantial equivalence. Mechanical properties testing was performed on the L1 MMF screws to demonstrate the torsional properties, driving torque, and axial pullout strength. All screw test articles successfully completed testing without any signs of device failure.
Pyrogenicity Testing: LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject device plates and screws to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin L1 MMF System devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications.
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.
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.
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
February 23, 2018
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
KLS Martin LP Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
Re: K173320
Trade/Device Name: KLS Martin L1 MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 17, 2017 Received: October 20, 2017
Dear Gary Moore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 may be subject to additional controls. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
KLS Martin L1 MMF System
Indications for Use (Describe)
The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray, and "L.P." is in black. Above the logo is the text "K173320".
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Section 5 510(k) Summary 21 CFR 807.92
| Submitter: | KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Moore
Quality Management and Regulatory Affairs Manager
Phone: 800-625-1557
Email: gmoore@klsmartin.com |
| Date Prepared: | January 25, 2018 |
| Trade Name: | KLS Martin L1 MMF System |
| Common Name: | Plate, Bone |
| Classification Name: | Bone plate (21 CFR 872.4760) |
| Regulatory Class: | II |
| Product Code: | JEY |
| Predicate Devices: | Synthes MatrixWAVE MMF System (K141165) - Primary
Stryker Universal SMARTLock Hybrid MMF System
(K122313)
Biomet Microfixation OmniMax MMF System (K143336) |
| Reference Device: | Internal Distraction - Sterile (K161470) |
| Device Description: | The KLS Martin L1 MMF System is a bone-borne
maxillomandibular fixation (MMF) system consisting of
metallic archbars with sliding locking plates that attach to the
dental arches with self-drilling locking screws. The system is
intended to provide temporary stabilization of mandibular
and maxillary fractures as well as maintain proper occlusion
during intraoperative bone fixation and postoperative bone
healing (app. 6-8 weeks). The patient is brought into
occlusion by wiring around the archbar wire hooks. The L1
MMF system plates are manufactured from CP Titanium
(ASTM F67:2013), are available in either a 7-hole or 9-hole
sliding plate configuration with two different lengths, and are
0.5 mm in plate thickness. The L1 MMF system sliding
locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8
mm self-drilling locking screws manufactured from Ti-6Al-
4V (ASTM F136:2013). Implants are available both sterile
and non-sterile. The system also includes the necessary
instruments to facilitate placement of the implants. |
4
Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters/word in the logo.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
The KLS Martin L1 MMF System is intended for temporary Indications for Use: stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).
5
KLS martın L.P.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Technological Characteristics/Substantial Equivalence Discussion:
| | KLS Martin L1 MMF System
(Subject Device) | Synthes MatrixWAVE System
(Primary Predicate) | Stryker Universal
SMARTLock Hybrid
MMF System
(Predicate) | Biomet Microfixation
OmniMax MMF
System
(Predicate) | KLS Martin Internal
Distraction – Sterile
(Reference Device) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The KLS Martin L1
MMF System is
intended for temporary
stabilization of
mandibular and
maxillary fractures. It is
designed to maintain
proper occlusion during
intraoperative bone
fixation and
postoperative bone
healing (app. 6-8
weeks). It is indicated
for the temporary
treatment of
maxillomandibular
fixation (MMF) in
adults or adolescents
who have permanent
teeth present (ages 12
and older). | Intended Use: The system
is intended for temporary
stabilization of
mandibular and maxillary
fractures and osteotomies
to maintain proper
occlusion during
intraoperative bone
fixation and postoperative
bone healing
(approximately 6-8
weeks). The system
affords the ability to
compress bone segments
across a fracture. The
system is not intended to
be used as a tension band.
Indications for Use: The
MatrixWAVE MMF
System is indicated for
the temporary treatment
of mandibular and
maxillary fractures and
osteotomies in adults and
adolescents (age 12 and
higher) in whom
permanent teeth have
erupted. | Intended Use: The
Stryker Universal
SMARTLock Hybrid
MMF System is intended
to be used for temporary
stabilization of
mandibular and
maxillary fractures in
order to maintain proper
occlusion during fracture
healing.
Indication for Use: The
Stryker Universal
SMARTLock Hybrid
MMF System is
indicated for the
treatment of mandibular
and maxillary fractures
in adults and adolescents
(age 12 and higher) in
whom permanent teeth
have erupted. | The Biomet
Microfixation OmniMax
MMF System is
indicated for temporary
stabilization of
mandibular and
maxillary fractures to
maintain proper
occlusion during surgery
and for post-operative
fracture healing in adults
and adolescents (age 12
and older) in whom
permanent teeth have
erupted. | Internal Distraction -
Sterile includes
devices intended as
bone stabilizers and
lengthening (and or
transport) devices for
correction of
congenital deficiencies
or post traumatic
defects of the
mandible (including
ramus, body, alveolar
ridge, palate,
symphysis) and mid-
face bones that require
gradual distraction. |
| Contraindications | 1. Active or latent
infection.
2. Patients with limited
blood supply,
insufficient quantity or | 1. Unstable fractures that
cannot be stabilized in
occlusion using the
system.
2. Patients in whom | Unknown | 1. Patients with mental
or neurological
conditions who are
unwilling or incapable of
following postoperative | 1. Active infection.
2. Patient conditions
including: blood
supply
limitations. |
| KLS Martin L1 MMF
System | Synthes MatrixWAVE
System | Stryker Universal
SMARTLock Hybrid
MMF System | Biomet Microfixation
OmniMax MMF
System | KLS Martin Internal
Distraction - Sterile | |
| (Subject Device) | (Primary Predicate) | (Predicate) | (Predicate) | (Reference Device) | |
| quality of bone. Patients
with poor bone density
in whom failure of
screw fixation may be
anticipated.
3. Patients who are
unwilling or unable to
adhere to restriction in
eating and mouth
opening associated with
maxillomandibular
fixation.
4. Patients with mental
or neurological
conditions who are
unwilling or incapable
of following
postoperative care
instructions.
5. Severely comminuted
fractures or unstable
fractures.
6. Foreign body
sensitivity. Where
material sensitivity is
suspected, testing is to
be completed prior to
implantation.
7. Patients in whom
damage to un-erupted
permanent teeth is
anticipated.
8. Adolescents whose
permanent teeth have
NOT erupted | damage to un-erupted
permanent teeth by screw
insertion may be
anticipated.
3. Patients for whom
maxillomandibular
fixation represents a
higher than usual
psychological or
physical risk.
4. Patients who are
unwilling to adhere to
restrictions in eating and
mouth opening
associated with
maxillomandibular
fixation
5. Patients with poor bone
density in whom failure of
screw fixation may be
anticipated. | | care
instructions.
2. Patients with limited
blood supply,
insufficient quantity or
quality of bone.
3. Foreign body
sensitivity; where
material sensitivity is
suspected, testing is to
be completed prior to
implantation.
4. Severely comminuted
fractures or unstable
fractures.
5. Active or latent
infection.
6. Patients in whom
damage to un-erupted
permanent teeth is
anticipated. | insufficient quantity or
quality of bone or
latent infections.
3. Patients with mental
or neurologic
conditions who are
unwilling or incapable
of following
postoperative care
instructions.
4. Foreign body
sensitivity - Where
material sensitivity is
suspected, tests are to
be made prior to
implantation. | |
| | KLS Martin L1 MMF
System
(Subject Device) | Synthes MatrixWAVE
System
(Primary Predicate) | Stryker Universal
SMARTLock Hybrid
MMF System
(Predicate) | Biomet Microfixation
OmniMax MMF
System
(Predicate) | KLS Martin Internal
Distraction – Sterile
(Reference Device) |
| Product Code | JEY | JEY | JEY | JEY | HRS |
| Material | Plates: CP Titanium
Screws: Titanium Alloy | Plates: CP Titanium
Screws: Titanium Alloy | Plates: CP Titanium
Screws: Titanium Alloy | Plates: CP Titanium
Screws: Titanium Alloy | CP Titanium &
Titanium Alloy |
| Sterilization | Sterile (gamma
irradiation) and Non-
sterile (steam) | Non-sterile | Non-sterile | Non-sterile | Sterile (gamma
irradiation) |
| Target
Population | Adolescents and Adults | Adolescents and Adults | Adolescents and Adults | Adolescents and Adults | Not applicable |
| Anatomical Sites | Mandibular and
Maxillofacial Areas | Mandibular and
Maxillofacial Areas | Mandibular and
Maxillofacial Areas | Mandibular and
Maxillofacial Areas | Mandibular and
Maxillofacial Areas |
| Plate/Archbar
Thickness | 0.5 mm | 1.0 mm | 0.5 mm | unknown | Not applicable |
| Plate/Archbar
Length | 109.5 mm and 130 mm | Variable, depending on
stretching of plate | 110 mm and 130 mm | Unknown | Not applicable |
| Screw Diameter | 2.0 mm | 1.85 mm | 2.0 mm | 2.0 mm | Not applicable |
| Screw Length | 6 and 8 mm | 6 and 8 mm | 6 and 8 mm | 7, 9, and 11 mm | Not applicable |
| Screw Style | self-drilling, locking | self-drilling, locking | self-drilling, locking | self-drilling, locking | Not applicable |
6
kıs martın L.P.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
7
KLS MG
11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Similarities to Predicates
The subject and predicate device systems are identical with respect to intended use and materials. All devices are intended for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occusion during intractor and postoperative healing, Both subject and predicate device plates are manufactured from CP Titanium, while screws are manufactured from Titanium Alloy. All devices have very similar principles of operation, design, and device mechanisms: metallic plates and screws each fixated to the maxilla, then wired together to achieve maxillomandibular fixation (MMF). Anatomical sites and fixation methods used for the subject and predical. All device systems use self-drilling screws, have a locking plate/screw interface, have plates that can be cut and hooks to support wires or elastics. The subject and predicate devices are for prescription use only by qualified and trained physicians in healthcare facilities/hoopitals.
8
Image /page/8/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo.
Differences to Predicates
The subject and predicate devices are slightly different in regard to screw design, screw diameter, and screw lengths. The Synthes MatrixWave screw has a raised head with a groove to accommodate wire(s) for additional stability. The subject device screw is not designed to be used as additional support for wires. In addition, the subject device has a bigger screw head diameter than the Synthes MatrixWave screws. Screw lengths are the same among the subject and predicate devices, with the exception of Biomet OmniMax which offers screws in greater lengths. The subject device plates are designed to allow variability in screw hole placement, whereas the Biomet OmniMax and Stryker Universal SMARTLock only offer plates with predetermined screw hole locations. Finally, the predicate device systems are provided non-sterile and must be sterilized by the end-user. The subject device components will be provided sterile. Sterile subject devices are provided in sterile packaging via gamma irradiation.
Reference Devices
The KLS Martin L1 MMF System includes devices manufactured from the same materials as the reference device. The subject devices are also identical in manufacturing process, biocompatibility, sterilization, and packaging as the reference devices cleared under K161470 - Internal Distraction - Sterile.
Non-Clinical Performance Data:
Mechanical Properties Testing
Tensile testing to demonstrate the maximum tensile strength of the L1 MMF System devices was performed and compared with the tensile strength of the Synthes MatrixWAVE MMF System (K141165). Results of the testing show the subject device system has an equal or greater tensile force than the predicate device, therefore demonstrating substantial equivalence. Mechanical properties testing was performed on the L1 MMF screws to demonstrate the torsional properties, driving torque, and axial pullout strength. All screw test articles successfully completed testing without any signs of device failure.
Pyrogenicity Testing
LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject device plates and screws to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin L1 MMF System devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications.
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
9
Image /page/9/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.
Conclusion:
The KLS Martin L1 MMF System has the same intended use and very similar technological characteristics as the predicate devices. Technological differences have been assessed with performance testing presented in this submission. Testing has demonstrated that any differences in technological characteristics do not raise new issues of safety or effectiveness and concludes the subject device is substantially equivalent to the predicate devices.