Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a process of patient-specific device design based on CT scans and physician input, with verification performed by virtually fitting the implant. There is no mention of automated learning, pattern recognition, or algorithms that adapt or improve over time, which are characteristic of AI/ML. The process appears to be a form of computer-aided design and manufacturing (CAD/CAM) with human oversight and input.

Therapeutic

No.
The device is used for stabilization, fixation, and reconstruction of bone, which are considered non-therapeutic structural functions.

Diagnostic

No

The device is a patient-specific implant designed for stabilization, fixation, and reconstruction of skeletal regions, not for diagnosing conditions. It uses pre-existing CT scan data for design and manufacturing but does not perform diagnostic functions itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of "patient-specific metallic bone plates" which are physical hardware components. While software is used in the planning and design process, the final medical device is a physical implant.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description: The TECHFIT Patient-Specific Maxillofacial System is a physical implant (bone plates) used for stabilization, fixation, and reconstruction of bones. It is manufactured based on medical imaging and physician input, but it does not perform any tests on biological samples.
Intended Use: The intended use is for surgical implantation to support and reconstruct bone structures, not for diagnostic testing.

The device is a surgical implant, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.

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

JEY

Device Description

TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.

The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.

Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT scan

Anatomical Site

Maxillofacial/Midface & Mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Bending & Fatigue testing:
Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the subject plates against plates previously cleared in reference device K032442. The bending resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K032442 plates.

Biocompatibility:
For the assessment of biological endpoints, the procedures and provisions of ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as well as FDA Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process", dated 16. June 2016, were applied.

Sterilization:
Sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and ISO 14937 to a sterility Assurance Level (SAL) of 10th. All test method acceptance criteria were met.

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.

KLS Martin Individual Patient Solutions (K191028)

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.

AFFINITY - Variable Angle Distal Radius System (K191641), KLS Martin Mandibular / Reconstruction System II (K032442)

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

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 19, 2021

Industrias Medicas Sampedro S.A.S. Leidy Gonzalez Regulatory Affairs Specialist Carrera 47 N 100 Sur 40 Centro Industrial Portal del Sur Bodega 14 La Estrella, Antioquia 055468 COLOMBIA

Re: K203282

Trade/Device Name: TECHFIT Patient-Specific Maxillofacial System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 16, 2021 Received: April 19, 2021

Dear Leidy Gonzalez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

1

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) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203282

Device Name

TECHFIT Patient-Specific Maxillofacial System

Indications for Use (Describe)

TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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 "sampredo SISTEMAS DE FIJACIÓN ÓSEA". The logo is in green and features the word "sampredo" in a bold, sans-serif font. The letter "p" in "sampredo" is stylized with a vertical line that extends below the baseline and has a series of short, horizontal lines on the left side. Below "sampredo" is the text "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.

Image /page/3/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the word "TECHFIT" in large, bold letters. Below "TECHFIT" are the words "Digital Surgery" in a smaller, lighter font. The graphic above the text features a black circle with a crescent-shaped cutout, and a smaller black circle overlapping the larger one.

K203282 510(k) Summary 21 CFR 807.92

| Submitter | Industrias Médicas Sampedro S.A.S.
Carrera 47 Nº 100 Sur 40
Centro Industrial Portal del Sur, Bodega 14
La Estrella, Colombia, 055468 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leidy Johanna Toro-González
Regulatory Affairs Specialist
Phone: +574 322 3375
Email: leidy.toro@imsampedro.com |
| Date Prepared: | May 18, 2021 |
| Trade Name:
Common Name: | TECHFIT Patient-Specific Maxillofacial System
Plate, Bone |
| Clasification Name: | Bone plate |
| Regulatory Class: | II |
| Product Code: | JEY |
| Regulation Number: | 21 CFR 872.4760 |
| Primary Predicate: | KLS Martin Individual Patient Solutions (K191028) |
| Reference Devices: | AFFINITY - Variable Angle Distal Radius System (K191641)
KLS Martin Mandibular / Reconstruction System II (K032442) |

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Image /page/4/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACION OSEA". The logo is in green and the "p" in "sampredro" is stylized to look like a medical device. The text "SISTEMAS DE FIJACION OSEA" is in a smaller font and is located below the main text.

ra 47 Nº 100 Sur 40 ustrial Portal del Sur. Bodega 14 strella. Colombia.

Image /page/4/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo features a stylized graphic above the company name. The graphic consists of two overlapping circles, one larger and one smaller, both filled in black. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font. Underneath "TECHFIT", the words "Digital Surgery" are written in a smaller, lighter font.

Device Description:

TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.

The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.

Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).

Indications for Use

TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.

Technological Characteristics & Substantial Equivalence Discussion

SISTEMAS DE FIJACIÓN ÓSEA The intended use of the subject device, TECHFIT Patient-Specific Maxillofacial System, is the same as the primary predicate device, KLS Martin Individual Patient Solutions (K191028). The only difference is that the predicate device can also be manufactured from another material, titanium alloy Ti6Al4V, through additive manufacturing and selective laser melting.

Similarities to Predicate

The subject and primary predicate devices are both intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions and share the same fundamental principles of operation - patient-specific metallic bone plates used in conjunction with metallic bone screws for facial reconstructive surgery.

Both the subject and predicate devices are manufactured to match the patient's anatomy. The design process for both the subject and the predicate device use image data obtained from medical scanners, such as a CT scan.

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Image /page/5/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACION OSEA". The word "sampredro" is written in a sans-serif font in green. The "i" in "sampredro" is replaced by a green image of a screw. Below the word "sampredro" is the phrase "SISTEMAS DE FIJACION OSEA" in a smaller, sans-serif font in gray.

Image /page/5/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic appears to be two overlapping circles, one larger and solid black, and the other smaller and partially covering the larger one. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.

The subject and predicate devices plates are manufactured from the same material. CP Titanium (ASTM F67), and they are manufactured using the traditional (subtractive) manufacturing method.

All subject and predicate devices are provided non-sterile and require the end-user to process the devices using validated cleaning and sterilization methods prior to use as recommended in the device labeling.

Differences from Predicate

The predicate device can also be manufactured from titanium alloy (Ti-6Al-4V) through additive manufacturing and selective laser melting, whereas the subject device is manufactured only from CP titanium through the traditional subtractive method.

Reference Devices

The AFFINITY - Variable Angle Distal Radius System (K191641) was selected as reference device as it is manufactured with identical material (CP Titanium) and follow similar manufacturing methods to those of the subject device. Screws from this system are manufactured from titanium alloy Ti6Al4V.

The KLS Martin Mandibular Reconstruction System II (K032442) was selected as reference device solely for the side-by-side mechanical performance testing with the TECHFIT Patient-Specific Maxillofacial System. The KLS Martin Mandibular Reconstruction System II plates dimensions are comparable to the subject device. Both plate thickness and length of this reference device fall within the range of the subject device.

A device comparison table of the subject, predicate, and reference devices is provided below.

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Image /page/6/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampredro" is written in a sans-serif font in green. The letter "p" in "sampredro" is stylized with a green line that extends below the word. Below "sampredro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.

Image /page/6/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is composed of two overlapping circles, one solid black and the other a partial circle. Below the graphic is the word "TECHFIT" in a bold, sans-serif font, with the words "Digital Surgery" in a smaller font size underneath.

	Subject Device	Predicate Device	Reference device 1	Reference Device 2
Parameters	TECHFIT patient-
specific Maxillofacial
System	KLS Martin Individual
Patient Solutions	AFFINITY -
Variable Angle Distal
Radius System	KLS Martin
Mandibular
Reconstruction
System II
510K number	K203182	K191028	K191641	K032442
Indications for
Use	TECHFIT Patient-
Specific Maxillofacial
System is intended for
use in the stabilization,
fixation, and
reconstruction of the
maxillofacial/midface
and mandibular skeletal
regions.	KLS Martin Individual
Patient Specific
Solutions implant
devices are intended for
use in the stabilization,
fixation, and
reconstruction of the
maxillofacial/midface
and mandibular skeletal
regions.	Fixation of simple and
complex intraarticular
and extraarticular
fractures, and for
osteotomies of the
distal radius in adults.
Fractures AO types
A2, A3, B1, B3, C1,
C2, C3.	The KLS Martin
Mandibular
Reconstruction
System II is intended
for use in the
stabilization and
fixation of mandibular
fractures and
mandibular
reconstruction.
Patient-specific	Yes. Devices are
manufactured
patient-specific, based on
a CT scan of the patient.	Yes. Devices are
manufactured
patient-specific, based on
a CT scan of the patient.	No. Devices are
provided in standard
shape.	No. Devices are
provided in standard
shape.
Classification	Class II. CFR 872.4760;
Bone plate	Class II. CFR 872.4760;
Bone plate	Class II 21 CFR
882.5320;
Single/multiple
component metallic
bone fixation
appliances and
accessories	Class II 21 CFR
872.4760; Bone plate
Product code	JEY (Bone plate)	JEY (Bone plate)	HRS (Single/multiple
component metallic
bone fixation
appliances and
accessories)
HWC (Smooth or
threaded metallic bone
fixation fastener)	MQN (External
Mandibular Fixator
And/or Distractor)
Plates Material	Plates: biocompatible
commercially pure
titanium grade 4	Plates: biocompatible
commercially pure
titanium grade 4	Plates: biocompatible
commercially pure
titanium grade 4
(ASTM F67)	Commercially pure
(CP)
Titanium or Ti-6AL-
4V Titanium Alloy
	Subject Device	Predicate Device	Reference device 1	Reference Device 2
Parameters	TECHFIT patient-
specific Maxillofacial
System	KLS Martin Individual
Patient Solutions	AFFINITY -
Variable Angle Distal
Radius System	KLS Martin
Mandibular
Reconstruction
System II
510K number	K203182	K191028	K191641	K032442
		Biocompatible titanium
alloy (Ti6Al4V)
Manufacturing
Method	Traditional (Subtractive)	CP Titanium: Traditional
(Subtractive) Ti-6Al-4V:
Traditional and 3D
(Additive; Selective
Laser Melting)	Traditional
(Subtractive)	Traditional
(Subtractive)
Sterilization	Steam Sterilization	Steam Sterilization	Steam Sterilization	Steam Sterilization
Anatomical
Sites	Maxillofacial/ Midface
& Mandible	Maxillofacial/ Midface
& Mandible	Radius	Mandible
Plate specifications
Thickness	Maxillofacial
reconstruction: 0.6 mm –
2.0 mm
Midface reconstruction:
0.6 mm – 10 mm
Mandibular
reconstruction: 2.0 mm –
3.0 mm	Maxillofacial / midface
reconstruction:0.6 mm –
10 mm
Mandibular
reconstruction:
1.0 mm-3.0 mm
Orbital:
0.3 mm – 1.0mm	Extraarticular plates:
From 1.9 mm to 2.
5mm
L-plates, T-plates,
Straight plates: 1.6
mm	1.0 mm – 3.0 mm
Width	Maxillofacial / midface:
Min: ≥ 4.5 mm (around
screw holes)
Min: ≥ 3 mm (not around
screw hole)
Max: Dependent on
screw-hole
Mandibular:
Min: 6.63 mm	Maxillofacial / midface:
Min: ≥ 4.5 mm (around
screw holes)
Min: ≥ 3 mm (not around
screw hole)
Max: Dependent on
screw-hole
Mandibular:
Min: 7 mm	Extraarticular wide
plates:
27 mm (head)
9.8 mm (body)
Extraarticular
intermediate plates:
25 mm (head)
9.8 mm (body)	Unknown
	Subject Device	Predicate Device	Reference device 1	Reference Device 2
Parameters	TECHFIT patient-
specific Maxillofacial
System	KLS Martin Individual
Patient Solutions	AFFINITY -
Variable Angle Distal
Radius System	KLS Martin
Mandibular
Reconstruction
System II
510K number	K203182	K191028	K191641	K032442
			Extraarticular narrow
plates:
22.8 mm (head)
9.8 mm (body)

L-plates, T-plates:
14 mm (head)
7 mm (body)

Straight plate:
7 mm (body) | |
| Length | Maxillofacial / midface:
Min: 18 mm
Max: 350 mm

Mandibular:
Min: 78 mm
Max: 320 mm | Maxillofacial / midface:
Min: 18 mm
Max: 350 mm

Mandibular:
Min: 31 mm
Max: 320 mm | Extraarticular
intermediate plates:
37 mm
53 mm
94 mm

Extraarticular wide
plates:
53 mm

Extraarticular narrow
plates:
37 mm
53 mm

L-plates, T-plates,
Straight plate:
38 mm
52 mm | Unknown |
| Degree of
Curvature (in-
plane) | Maxillofacial/midface:
Min: 30°
Max: 180°

Mandibular:
Min: 90°
Max: 180° | Maxillofacial/midface:
Min: 30°
Max: 180°

Mandibular:
Min: 90°
Max: 180° | Extraarticular plates:
There is no degree of
curvature (in-plane).

Straight plate:
3 segments plates:
2 VA holes
1 Oblong hole
4 segments plates:
3 VA holes
1 Oblong hole
6 segments plates:
5 VA holes
1 Oblong hole | |
| Fixation
method | The implant is attached
to the bone with FDA
cleared commercially
available screws. | These patient-specific
devices are fixated with
previously cleared KLS
Martin screws. | AFFINITY – Variable
Angle Distal Radius
System is fixed with
screws. | KLS Martin
Mandibular
Reconstruction
System II is fixed with
screws. |
| Manufacturer | Industrias Médicas
Sampedro | KLS Martin L.P. | Industrias Médicas
Sampedro | KLS Martin L.P. |

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Image /page/7/Picture/0 description: The image contains the logo for "sampredo SISTEMAS DE FIJACION OSEA". The word "sampredo" is written in a large, sans-serif font and is colored in a light green. Below the word "sampredo" is the phrase "SISTEMAS DE FIJACION OSEA" written in a smaller, sans-serif font. To the left of the "p" in "sampredo" is a graphic of a screw.

Image /page/7/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is a black circle with a white crescent shape cut out of it, and a smaller black circle overlapping the top right of the larger circle. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.

8

Image /page/8/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampredro" is written in a sans-serif font in green. The letter "p" in "sampredro" is stylized with a green line that extends below the word. Below "sampredro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.

Image /page/8/Picture/2 description: The image shows the logo for TECHFIT Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is a black circle with a smaller, crescent-shaped piece taken out of the upper right quadrant, creating a modern and abstract design. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and beneath that, the words "Digital Surgery" are written in a smaller, lighter font.

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Image /page/9/Picture/0 description: The image shows the logo for "sampredro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampredro" is written in a sans-serif font in green. The letter "p" in "sampredro" is stylized with a green line that extends below the word. Below "sampredro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA" in a smaller, sans-serif font.

Image /page/9/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic is composed of two overlapping circles, one solid black and the other a partial circle. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.

10

Image /page/10/Picture/0 description: The image shows the logo for "sampedro SISTEMAS DE FIJACIÓN ÓSEA". The word "sampedro" is written in a green sans-serif font, with the "p" stylized to resemble a medical device. Below the word "sampedro" is the phrase "SISTEMAS DE FIJACIÓN ÓSEA", which is written in a smaller, sans-serif font.

Image /page/10/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a stylized graphic above the company name. The graphic features a black circle with a white crescent shape cut out of it, and a smaller black circle overlapping the larger one. Below the graphic, the word "TECHFIT" is written in a bold, sans-serif font, and below that, the words "Digital Surgery" are written in a smaller, lighter font.

Performance Testing – Non-clinical

Bending & Fatigue testing:

Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the subject plates against plates previously cleared in reference device K032442. The bending

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Image /page/11/Picture/0 description: The image shows the logo for "sampredo SISTEMAS DE FIJACION OSEA". The word "sampredo" is written in a large, sans-serif font in a light green color. The "l" in "sampredo" is stylized to look like a medical device. Below "sampredo" is the phrase "SISTEMAS DE FIJACION OSEA" in a smaller, sans-serif font.

Image /page/11/Picture/2 description: The image shows the logo for Techfit Digital Surgery. The logo features a stylized graphic of two overlapping circles, one black and one white, above the word "TECHFIT" in a bold, sans-serif font. Below "TECHFIT" are the words "Digital Surgery" in a smaller, lighter font.

resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K032442 plates.

Biocompatibility:

For the assessment of biological endpoints, the procedures and provisions of ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as well as FDA Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process", dated 16. June 2016, were applied.

Sterilization:

Sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and ISO 14937 to a sterility Assurance Level (SAL) of 10th. All test method acceptance criteria were met.

Performance Testing - Clinical:

Clinical testing was not necessary for the substantial equivalence determination.

Substantial Equivalence Conclusion

SISTEMAS DE FIJACION OSEA

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate / reference devices, the TECHFIT Patient-Specific Maxillofacial System shows to be substantially equivalent to the predicate devices.