510(k) · Cleared

Cleared

Saiph Knee System

K140222510(k) TraditionalCleared Nov 17, 2014292-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Matortho · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Nov 17, 2014 as substantially equivalent to K020214 (Engineering Consulting Services, Inc., 2002) and 8 other predicates after a 292-day review. Its family tree reaches back 2 generations to 1983.

Decided: Nov 17, 2014
Review: 292 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 9

Its longest line of descent runs back 2 generations to K830726 (1983). 16 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK830726 Mark I & II Total Knee Replace. SysAdvanced Biosearch Assn. · 1983
1 generation backK020214 Medial Rotation Knee SystemEngineering Consulting Services, Inc. · 2002
This deviceK140222 Saiph Knee SystemMatortho · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K830726	Mark I & II Total Knee Replace. Sys	Advanced Biosearch Assn.	1983	—
−1	K020214	Medial Rotation Knee System	Engineering Consulting Services, Inc.	2002	—
0 (this device)	K140222	Saiph Knee System	Matortho	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1994	1	0
1995	4	0
1996	1	0
1997	2	0
1999	2	0
2001	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K140222, 1983–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K020214	Medial Rotation Knee System Summary page 4 …hesis (Class II) Classification panel Orthopedic Regulation 21 CFR 888.3560 Product Code(s) 87JWH Legally marketed device(s) K020214 - Medial Rotation Knee™ (MRK) System (JWH) to which equivalence is K023211 - NexGen® Complete Knee Solution Cruciate claimed…	Engineering Consulting Services, Inc.	2002	—
*	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components Summary page 4 …21 CFR 888.3560 Product Code(s) 87JWH Legally marketed device(s) K020214 - Medial Rotation Knee™ (MRK) System (JWH) to which equivalence is K023211 - NexGen® Complete Knee Solution Cruciate claimed Retaining (CR)-Flex Femoral Components (JWH)…	Zimmer, Inc.	2002	6
*	K003910	Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR)… Summary page 4 …s K023211 - NexGen® Complete Knee Solution Cruciate claimed Retaining (CR)-Flex Femoral Components (JWH) K003910 - NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articula…	Zimmer, Inc.	2001	65
*	K963148	Nexgen Complete Knee Solution Summary page 4 …Polyethylene Cruciate Retaining (CR) Articular Surface Components (JWH) K963148 - NexGen® Complete Knee Solution (JWH) K031729 - Triathlon® PS Knee (JWH)…	Zimmer, Inc.	1997	1
*	K031729	Triathlon Posteriorly Stabilized (PS) Total Knee System Summary page 4 …Surface Components (JWH) K963148 - NexGen® Complete Knee Solution (JWH) K031729 - Triathlon® PS Knee (JWH) K935080 – Insall Burstein II K931466 – PFC M…	Howmedica Osteonics Corp.	2003	3
*	K935080	Insall-Burstein II Summary page 4 …K963148 - NexGen® Complete Knee Solution (JWH) K031729 - Triathlon® PS Knee (JWH) K935080 – Insall Burstein II K931466 – PFC Modular Total Knee System K946088 -…	Hospital For Special Surgery	1995	—
*	K931466	PFC Modular Total Knee System, Porous Coated Sacri Summary page 4 …nee Solution (JWH) K031729 - Triathlon® PS Knee (JWH) K935080 – Insall Burstein II K931466 – PFC Modular Total Knee System K946088 - Genesis® PS Knee…	Johnson & Johnson Orthopaedics, Inc.	1994	—
*	K946088	Genesis Posterior Stabilized (P/S) Knee System Summary page 4 …PS Knee (JWH) K935080 – Insall Burstein II K931466 – PFC Modular Total Knee System K946088 - Genesis® PS Knee K140222 (page 2…	Smith & Nephew Richards, Inc.	1995	—
*	K932070	Duracon Stabilizer Femoral Component and Insert Summary page 5 …088 - Genesis® PS Knee K140222 (page 2/4) K932070 - Duracon® Constrained PS Knee Reason for 510(k) New device submission Device description The Saiph® Knee S…	Howmedica Corp.	1995	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
7 of the 16 ancestors have a recall of any class.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: I. Non-inflammatory degenerative Joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis; 2. Inflammatory degenerative joint disease including rheumatoid arthritis: 3.…

Read the full statement (102 words)

I. Non-inflammatory degenerative Joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis:

3. Correction of varus, valgus, or post traumatic deformity;

4. Correction or revision of unsuccessful osteotomy or arthrodesis:

5. Revision procedures where other treatments or devices have failed; and

6. Treatment of fractures that are unmanageable using other techniques.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K140222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140222: Saiph Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140222

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026