Pectus Blu System
Device Facts
| Record ID | K261002 |
|---|---|
| Device Name | Pectus Blu System |
| Applicant | Biomet Microfixation |
| Product Code | HRS · Orthopedic |
| Decision Date | Jun 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Pectus Blu System is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
Device Story
Pectus Blu System consists of surgical implants, specifically support bars and stabilizers, used to treat Pectus Excavatum; device applies internal outward force to sternum to correct funnel-shaped deformity; implants are pre-bent and can be further shaped intraoperatively by surgeons; system supports both parallel and crossed bar orientations when multiple bars are used; stabilizers feature barbell-shaped geometry; intended for implantation for approximately 2-3 years; used in surgical settings by surgeons to improve patient chest wall structure.
Clinical Evidence
Bench testing only. Construct bending fatigue testing and MR compatibility evaluation were performed to demonstrate substantial equivalence to the predicate device.
Technological Characteristics
Metallic bone fixation appliances; includes support bars and barbell-shaped stabilizers; pre-bent design for intraoperative shaping; supports parallel or crossed orientation; MR compatible.
Indications for Use
Indicated for treatment of Pectus Excavatum and other sternal deformities in pediatric (children and adolescents) and adult populations.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- Pectus Blu Support Bar System (K241709)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 2, 2026
Biomet Microfixation
% Danielle Besal
Principal Consultant
MRC Global, LLC
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland, Tennessee 38002
Re: K261002
Trade/Device Name: Pectus Blu System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: HRS
Dated: April 9, 2026
Received: April 10, 2026
Dear Danielle Besal:
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 (the 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 available 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-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-devices/device-advice-comprehensive-regulatory-
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assistance/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,
**CHRISTOPHER FERREIRA -S**
Christopher Ferreira, M.S.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K261002
?
Please provide the device trade name(s).
?
Pectus Blu System
Please provide your Indications for Use below.
?
The Pectus Blu System is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
?
Please select the age group(s) for which the device(s) is to be used.
☐ Neonates/Newborns (Birth to < 29 days old)
☐ Infants (29 days old to < 2 years old)
☑ Children (2 years old to < 12 years old)
☑ Adolescents (12 years old to < 22 years old)
☑ Adults (22 years old and greater)
?
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K261002 - Page 1 of 2
510(k) #: K261002
# 510(k) Summary
Prepared on: 2026-04-09
# Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Biomet Microfixation |
| --- | --- |
| Applicant Address | 1520 Tradeport Dr Jacksonville FL 32218 United States |
| Applicant Contact Telephone | 904-741-4400 |
| Applicant Contact | Jose Ponce |
| Applicant Contact Email | jose.ponce@zimmerbiomet.com |
| Correspondent Name | MRC Global, LLC |
| Correspondent Address | 9160 HWY 64, STE 12 PO BOX 330 Lakeland TN 38002 United States |
| Correspondent Contact Telephone | 9018278670 |
| Correspondent Contact | Danielle Besal |
| Correspondent Contact Email | danielle.besal@askmrcglobal.com |
# Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Pectus Blu System |
| --- | --- |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Plate, Fixation, Bone |
| Regulation Number | 888.3030 |
| Product Code(s) | HRS |
# Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K241709 | Pectus Blu Support Bar System | HRS |
# Device Description Summary
21 CFR 807.92(a)(4)
The Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric patients (children and adolescents). The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively.
# Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Pectus Blu System is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in
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pediatric (children and adolescents) and adult populations.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are identical to those of the predicate.
## Technological Comparison
21 CFR 807.92(a)(6)
The addition of new stabilizer bars and the labeling change to allow implantation of the support bars in a crossed orientation do not change the fundamental design, operating principle, or intended use of the Pectus Blu System. The new stabilizer bars are made from the identical material and size range to the predicate device, but have a slightly different geometry featuring a barbell shape. The subject labeling change allows the surgeon the option of implanting the support bars in a crossed orientation (when multiple bars are used) versus a parallel support bar orientation in the predicate labeling. Both the subject and predicate devices allow implantation of multiple support bars and performance testing on the crossed bar configuration has demonstrated equivalency to that of the predicate parallel orientation.
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Construct bending fatigue testing and MR compatibility evaluation were successfully completed on the subject device and results demonstrated substantial equivalence to the predicate device.
