Pipeline Orthopedics: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pipeline Orthopedics” (first 2012, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 143 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 151 |
| 2013 | 6 | 141 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 | 6 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Pipeline Orthopedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131368 | NEO KNEE SYSTEM | JWH | 2013-10-03 | 143 |
| K132046 | PIPELINE KNEE SYSTEM | JWH | 2013-09-23 | 83 |
| K130353 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) | LPH | 2013-07-01 | 139 |
| K131237 | PIPELINE TOTAL HIP SYSTEM | LPH | 2013-06-13 | 43 |
| K123692 | PIPELINE KNEE SYSTEM | JWH | 2013-05-24 | 172 |
| K122500 | NEO PS KNEE SYSTEM | JWH | 2013-05-03 | 260 |
| K120313 | NEO CR KNEE SYSTEM | JWH | 2012-04-20 | 79 |
| K113122 | PIPELINE CR PRIMARY KNEE SYSTEM | JWH | 2012-03-20 | 151 |
| K112802 | PIPELINE TOTAL HIP SYSTEM | OQG | 2012-03-09 | 164 |
Recalls
openFDA lists no recalls under a recalling firm named Pipeline Orthopedics.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pipeline Biomedical Products, LLC (1 510(k)s)
- Pipeline Biotechnology (1 510(k)s)
- Pipeline Medical Products, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pipeline Orthopedics?
FDA lists 9 510(k) clearances under the applicant name “Pipeline Orthopedics” (first 2012, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pipeline Orthopedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pipeline Orthopedics is 143 days.
Which FDA product codes appear under Pipeline Orthopedics?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 6); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2); OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, 1).
Next steps
- See all 9 Pipeline Orthopedics clearances with predicates and recalls
- Run predicate analysis for product code JWH, Pipeline Orthopedics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.