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ENDOTEC, INC.

Last updated May 23, 2026

What ENDOTEC, INC. makes

Endotec, Inc. manufactures orthopaedic implants including cruciate-retaining total knee prostheses, ceramic-on-polyethylene total hip prostheses, bipolar humeral and femoral head components for hemiarthroplasty, total shoulder prostheses, resurfacing humeral and metallic hip prostheses, and non-bioabsorbable orthopaedic bone screws.

The company’s portfolio includes devices regulated as Class II and Class III under FDA requirements, with submissions recorded in the FDA 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Endotec, Inc. manufacture?

Endotec, Inc. specializes in orthopaedic implants, including devices like cruciate-retaining total knee prostheses, ceramic-on-polyethylene total hip prostheses, bipolar humeral and femoral head components for hemiarthroplasty, total shoulder prostheses, resurfacing humeral and metallic hip prostheses, and non-bioabsorbable orthopaedic bone screws. These products are designed to replace or repair damaged joints and bone structures.

Where is Endotec, Inc. based, and how does that affect its regulatory standing?

Endotec, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based system (Class II or Class III). This means submissions for these devices are tracked in FDA registries like the 510(k) and UDI databases, ensuring compliance with U.S. medical device authorization requirements.

Which regulatory registries list Endotec, Inc.’s devices, and why?

Endotec, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) submission is required for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures unique identification and traceability of Class II and Class III devices throughout their lifecycle. These registries help track compliance and authorization status for each device type.

How are Endotec, Inc.’s devices classified under FDA regulations?

Endotec, Inc.’s devices are classified as either Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are high-risk and require premarket approval (PMA) due to insufficient data to ensure safety and effectiveness through less stringent means. The classification depends on the device’s intended use and potential risk to patients.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 803488357

Catalogue (580)

Page 8 of 12

Device	Model / Reference	Registries	Class	Status
B-P Total Hip System	01-34-0128	FDA UDI	Class II	Active
B-P Total Knee System	04-33-0101	FDA UDI	Class II	Unknown
B-P Total Hip System	01-17-3244	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0309	FDA UDI	Class II	Active
B-P Total Knee System	04-33-0142	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0414	FDA UDI	Class II	Active
B-P Total Knee System	04-33-0143	FDA UDI	Class II	Unknown
B-P Total Hip System	01-04-0116	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0002	FDA UDI	Class II	Active
B-P Total Shoulder System	02-02-0448	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0461	FDA UDI	Class II	Unknown
B-P Total Shoulder System	02-04-0210	FDA UDI	Class II	Unknown
B-P Total Hip System	01-21-0110	FDA UDI	Class II	Unknown
B-P Total Knee System	04-34-0205	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0810	FDA UDI	Class II	Active
B-P Total Knee System	04-32-0601	FDA UDI	Class II	Unknown
B-P Total Hip System	01-02-3264	FDA UDI	Class II	Active
B-P Total Knee System	04-33-0135	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0313	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0003	FDA UDI	Class II	Unknown
B-P Total Hip System	01-04-0414	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0320	FDA UDI	Class II	Unknown
B-P Total Knee System	04-34-0206	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0664	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0516	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0424	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0463	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0004	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0618	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0718	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0319	FDA UDI	Class II	Unknown
B-P Total Knee System	04-31-1506	FDA UDI	Class II	Unknown
B-P Total Hip System	01-21-0114	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0511	FDA UDI	Class II	Active
B-P Total Shoulder System	02-04-0214	FDA UDI	Class II	Active
B-P Total Hip System	01-34-1028	FDA UDI	Class II	Active
B-P Total Knee System	04-31-1202	FDA UDI	Class II	Active
B-P Total Knee System	04-32-0312	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0816	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0120	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0411	FDA UDI	Class II	Unknown
B-P Total Knee System	04-31-2004	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0318	FDA UDI	Class II	Active
B-P Total Knee System	04-31-1205	FDA UDI	Class II	Active
B-P Total Knee System	04-31-2503	FDA UDI	Class II	Unknown
B-P Total Knee System	04-32-0361	FDA UDI	Class II	Unknown
B-P Total Knee System	04-33-0111	FDA UDI	Class II	Unknown
B-P Total Shoulder System	02-02-5244	FDA UDI	Class II	Active
B-P Total Hip System	01-02-4254	FDA UDI	Class II	Unknown
B-P Total Hip System	01-04-0109	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Endotec, Inc. has 20 recall records listed, all initiated between June 5, 2009, and September 21, 2011, with all records marked as terminated. The recalls involve the Beuchel-Pappas Mobile Bearing Knee System (BP Knee) due to unapproved mobile bearing components and multiple instances of the B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues, including validation failures, process variations, and inconsistent test results.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 21, 2011	Z-0441-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0440-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0432-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0433-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0438-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0436-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0434-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0443-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0437-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0435-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0431-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0439-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0442-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Jun 5, 2009	Z-1622-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1623-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1626-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1621-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1625-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1627-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1624-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.