Pangea Femur Reconstruction System
Device Facts
| Record ID | K261481 |
|---|---|
| Device Name | Pangea Femur Reconstruction System |
| Applicant | Stryker GmbH |
| Product Code | HSB · Orthopedic |
| Decision Date | Jun 29, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures. - Non-unions, malunions, and deformities. - Periprosthetic fractures. Additionally, the Trochanter Plates and Trochanter Attachment Plate are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy. When used with the T2 Alpha Femur Retrograde Nailing System, The Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.
Device Story
System consists of orthopedic implants (distal lateral/medial plates, proximal interlinking dowels, spanning attachments, attachment fixation screws) and non-sterile instrumentation; used for internal fixation/stabilization of femur fractures/osteotomies; line extension introduces new plates and longer interlinking dowels; expands compatibility with T2 Alpha Femur Retrograde Nailing System; operated by surgeons in clinical settings; provides mechanical stabilization of bone segments to facilitate healing; benefits include restoration of skeletal alignment and support for bone union.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing: bending fatigue strength (ASTM F382), construct fatigue strength, MRI safety (ASTM F2052, F2213, F2182, F2119), packaging validation (ISO 11607-1/2), and biocompatibility (ISO 10993).
Technological Characteristics
Plates: Ti6Al4V ELI (Type II anodization). Interlinking dowels: CoCr28Mo6. Mechanical fixation via plates and dowels. Provided sterile and non-sterile. Testing per ASTM F382 (bending fatigue), ASTM F2052/F2213/F2182/F2119 (MRI safety).
Indications for Use
Indicated for internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone (diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular); non-unions, malunions, deformities; periprosthetic fractures; and fixation of the greater trochanter (trochanteric fracture or osteotomy). For patients aged 12 years and older.
Regulatory Classification
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Predicate Devices
- Pangea Femur Reconstruction System (K253640)
- Dall-Miles Cable System (K202016)
- AxSOS 3 Ti System (K222381)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 29, 2026
Stryker GmbH
Megan Denbleyker
Senior Regulatory Affairs Specialist
Bohnackerweg 1
Selzach, 2545
Switzerland
Re: K261481
Trade/Device Name: Pangea Femur Reconstruction System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary Fixation Rod
Regulatory Class: Class II
Product Code: HSB, HRS, HWC
Dated: May 5, 2026
Received: May 5, 2026
Dear Megan Denbleyker:
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
{1}
K261481 - Megan Denbleyker
Page 2
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-
{2}
K261481 - Megan Denbleyker
Page 3
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
{3}
# 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.
K261481
?
Please provide the device trade name(s).
?
Pangea Femur Reconstruction System
Please provide your Indications for Use below.
?
The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures.
- Non-unions, malunions, and deformities.
- Periprosthetic fractures.
Additionally, the Trochanter Plates and Trochanter Attachment Plate are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy.
When used with the T2 Alpha Femur Retrograde Nailing System, The Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.
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)
?
K261481 Page 1 of 1
{4}
Stryker GMBH Pangea Femur Reconstruction System
Traditional 510(k) Premarket Notification
## 510(k) Summary
| **Proprietary name:** | Pangea Femur Reconstruction System |
| --- | --- |
| **Common name:** | Plate, fixation, bone Screw, fixation, bone |
| **Primary Product Code:** | HSB |
| **Regulation Number:** | 21 CFR 888.3020: Intramedullary fixation rod |
| **Associated Product Code(s):** | HRS HWC |
| **Regulation Number:** | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| **Device Class:** | Class II |
| **Sponsor:** | Stryker GmbH Bohnackerweg 1 2545 Selzach, Switzerland |
| **Contact Person:** | Megan DenBleyker Senior Regulatory Affairs Specialist 325 Corporate Dr Mahwah, NJ 07430 Phone: (267) 254-4276 megan.denbleyker@stryker.com |
| **Date Prepared:** | May 5, 2026 |
| **Predicate Device:** | Pangea Femur Reconstruction System (K253640, primary predicate) Dall-Miles Cable System (K202016) AxSOS 3 Ti System (K222381) |
| **Device Description:** | The Pangea Femur Reconstruction System, previously cleared in K253640, consists of implants (distal lateral/medial plates, proximal interlinking dowels, spanning attachments, and an attachment fixation screw), as well as non-sterile instrumentation. The subject of this 510(k) submission is to introduce new devices of the Pangea Femur Reconstruction System. This line extension consists of new plates and new, longer interlinking dowels. This submission also aims to expand the compatibility of the Pangea Femur Reconstruction |
510(k) Summary
K261481 Page 1 of 3
{5}
Stryker GMBH Pangea Femur Reconstruction System
Traditional 510(k) Premarket Notification
System with all nail diameters of the T2 Alpha Femur Retrograde Nailing System.
The plates are manufactured from Ti6Al4V ELI (Type II anodization) and will be provided both non-sterile and sterile packaged. The interlinking dowels are manufactured from CoCr28Mo6 and will be provided sterile.
# **Indications for Use:**
The Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures.
- Non-unions, malunions, and deformities.
- Periprosthetic fractures.
Additionally, the Trochanter Plates and Trochanter Attachment Plate are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy.
When used with the T2 Alpha Femur Retrograde Nailing System, the Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.
# **Comparison to predicate device:**
The trochanter plates differ from the predicates because they contain a Y-shaped, non-continuous proximal design. A comparison of the systems demonstrated that the subject Pangea Femur Reconstruction System is substantially equivalent to the predicate devices regarding intended use, indications, material, design and operational principles.
# **Performance Data:**
*Non-Clinical Performance:*
Non-clinical testing and comparative assessments to predicate devices demonstrated substantial equivalence. The following factors were considered:
- Bending fatigue strength per ASTM F382
- Construct fatigue strength
- MR assessment of magnetically induced displacement force per ASTM F2052, magnetically induced torque per ASTM F2213, RF-induced heating per ASTM F2182, and image artifacts per ASTM F2119.
- Packaging tests were performed according to ISO 11607-1 and ISO 11607-2.
- Biocompatibility evaluation according to ISO 10993 series
# **Conclusion:**
The subject Pangea Femur Reconstruction System is substantially equivalent to the previously cleared predicate devices: Pangea Femur
510(k) Summary
K261481 Page 2 of 3
{6}
Stryker GMBH Pangea Femur Reconstruction System
Traditional 510(k) Premarket Notification
Reconstruction System, Dall-Miles Cable System and AxSOS 3 Ti System.
The performance data and analyses demonstrate that:
- Any differences do not raise new questions of safety and effectiveness; and
- The subject devices are at least as safe and effective as the legally marketed predicate devices.
510(k) Summary
K261481 Page 3 of 3
