Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pipeline Orthopedics — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

143 daysmedian FDA review time

260 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K131368	NEO KNEE SYSTEM	Pipeline Orthopedics	2013-10-03	143
K132046	PIPELINE KNEE SYSTEM	Pipeline Orthopedics	2013-09-23	83
K130353	PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)	Pipeline Orthopedics	2013-07-01	139
K131237	PIPELINE TOTAL HIP SYSTEM	Pipeline Orthopedics	2013-06-13	43
K123692	PIPELINE KNEE SYSTEM	Pipeline Orthopedics	2013-05-24	172
K122500	NEO PS KNEE SYSTEM	Pipeline Orthopedics	2013-05-03	260
K120313	NEO CR KNEE SYSTEM	Pipeline Orthopedics	2012-04-20	79
K113122	PIPELINE CR PRIMARY KNEE SYSTEM	Pipeline Orthopedics	2012-03-20	151
K112802	PIPELINE TOTAL HIP SYSTEM	Pipeline Orthopedics	2012-03-09	164

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda