Johnson & Johnson Orthopaedics, Inc.
Braintree, MA, US
Johnson & Johnson Orthopaedics, Inc. appears in FDA device records in Braintree, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Johnson & Johnson Orthopaedics, Inc. between 1990 and 1994. The busiest year on record is 1994, with 11. The most recent is 1994, with 11.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI | JWH | Substantially Equivalent | |
| K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | LZO | Substantially Equivalent | |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | KWL | Substantially Equivalent | |
| K933275 | P.F.C. CERAMIC HIP HEAD | LZO | Substantially Equivalent | |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | LZN | Substantially Equivalent | |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | KWY | Substantially Equivalent | |
| K933867 | UNIVERSAL INSET PATELLA | JWH | Substantially Equivalent for Some Indications | |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | JWH | Substantially Equivalent for Some Indications | |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | LZO | Substantially Equivalent | |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | JWH | Substantially Equivalent | |
| K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT | JWH | Substantially Equivalent | |
| K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR | LZO | Substantially Equivalent | |
| K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | KWL | Substantially Equivalent | |
| K924984 | SPECIALIST(R) WALKER | FYH | Substantially Equivalent | |
| K924115 | ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS | JDI | Substantially Equivalent | |
| K913629 | JOHNSON AND JOHNSON POWER SYSTEM | HSZ | Substantially Equivalent | |
| K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL | HSX | Substantially Equivalent | |
| K910968 | P.F.C. UNICONDYLAR KNEE SYSTEM | HRY | Substantially Equivalent | |
| K904737 | GROSS HIP FEMORAL COMPONENT | JDI | Substantially Equivalent | |
| K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL | JWH | Substantially Equivalent | |
| K904300 | INSET PATELLAR COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT | JDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LZNCement Obturator
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- FYHSplint, Extremity, Noninflatable, External, Sterile
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Johnson & Johnson Orthopaedics, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Johnson & Johnson Orthopaedics, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain