510(k) · Cleared

Cleared

Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon

K111472510(k) TraditionalCleared Sep 6, 2011102-day reviewClass II21 CFR 888.3358

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

Tgm Medical · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Sep 6, 2011 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 6 other predicates after a 102-day review. Its family tree reaches back 7 generations to 1993. 4 later devices descend from it.

Decided: Sep 6, 2011
Review: 102 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 7

Its longest line of descent runs back 7 generations to K930712 (1993). 79 ancestors in all, the oldest K810258 (1981). 4 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
3 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
2 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
1 generation backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
This deviceK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
Descendant · cites it directly · 1 of its ownK121636 Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head…Tgm Medical, Inc. · 2012
Descendant · cites it directly · 0 of its ownK191826 KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020
Descendant · cites it directly · 0 of its ownK150576 TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
Descendant · cites it directly · 0 of its ownK121509 Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012

Most influential descendants

Showing 4 of 4 · See all

K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 2012 · cites it directly1descendant
K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020 · cites it directly0descendants
K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015 · cites it directly0descendants
K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K930712	P.F.C. Total Hip System Porous Coated Modular	Johnson & Johnson Orthopaedics, Inc.	1993	—
−6	K983014	Summit Acetabular System	Johnson & Johnson Professionals, Inc.	1998	—
−5	K000306	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	1
−4	K001534	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	—
−3	K031110	Apex Modular Acetabular Cup	Apex Surgical, LLC	2003	—
−2	K060635	Consensus Acetabular Shell System	Hayes Medical, Inc.	2006	—
−1	K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	2010	—
0 (this device)	K111472	Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr…	Tgm Medical	2011	—
+1	K121636	Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert	Tgm Medical, Inc.	2012	—
+1	K191826	KeYi Total Hip System	Beijing Keyi Medical Device Technology Co., Ltd.	2020	—
+1	K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	2015	—
+1	K121509	Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert	Tgm Medical, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1985	1	0
1986	2	0
1988	1	0
1992	2	0
1993	1	0
1994	13	0
1995	7	0
1996	11	0
1997	5	0
1998	3	0
1999	4	0
2000	4	0
2001	3	0
2002	4	0
2003	5	0
2005	1	0
2006	1	0
2007	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2015	1	0
2020	1	0

FIG. 1 — Lineage of K111472, 1993–2020Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (7)

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
*	K922561	Consensus (TM) Total Hip System Summary page 2 …eviously cleared hip components to TOM Medical, Inc. The hip components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titanium bone screws (K922561). The…	U.S. Medical Products, Inc.	1993	—
*	K960339	Consensus 22MM Cocrmo Femoral Head Summary page 2 …cleared hip components to TOM Medical, Inc. The hip components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titanium bone screws (K922561). The HI-S hip…	U.S. Medical Products, Inc.	1996	—
*	K960156	Consensus 32MM Cocrmo Femoral Head Summary page 2 …omponents to TOM Medical, Inc. The hip components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titanium bone screws (K922561). The HI-S hip components th…	U.S. Medical Products, Inc.	1996	—
*	K960340	Consensus Apex Dome Hole Plug Summary page 2 …_____________ ______ K960156 Consensus 32mm CoCrMo Femoral U.S. Medical Products, Inc. 02/21/1996 Head K960340 Consensus Apex Dome Hole Plug U.S. Medical Products, Inc. 03/15/1996 K 102399 Consensus TaperSet Hip Syste…	U.S. Medical Products, Inc.	1996	—
*	K102399	Consensus Taperset Hip System Summary page 2 …, Inc. (COI) licensed their previously cleared hip components to TOM Medical, Inc. The hip components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titani…	Consensus Orthopedics, Inc.	2010	—
*	K100933	Consensus CS2 Plus Acetabular Insert Summary page 2 …sus Apex Dome Hole Plug U.S. Medical Products, Inc. 03/15/1996 K 102399 Consensus TaperSet Hip System Consensus Orthopedics, Inc. 12/02/2010 K100933 C52 Plus Acetabular Insert Consensus Orthopedics, Inc. 10/06/2010 KO20153 Cosnu ctblrSel…	Consensus Orthopedics, Inc.	2010	—
*	K020153	Consensus Acetablar Shell, TI Coated Summary page 2 …components consist of the previously cleared TaperSet Hip System femoral stem (K102399), CoCr femoral heads (K922561, K960339, and K960156), UHMWPE inserts (K922561 and K020153), acetabular shell (K922561) and titanium bone screws (K922561). The HI-S hip components therefore have the same technological ch…	Hayes Medical, Inc.	2002	—

Also cleared against K922561: 10 other devices →

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121636	Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert	Tgm Medical, Inc.	2012	1
K191826	KeYi Total Hip System	Beijing Keyi Medical Device Technology Co., Ltd.	2020	0
K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	2015	0
K121509	Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert	Tgm Medical, Inc.	2012	0

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 18 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
9 of the 79 ancestors have a recall of any class.
Of its descendants, K121636 (Tgm Medical, Inc., 2012) has gone furthest, with 1 descendant of its own.
10 other devices also cite its predicate K922561.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The HELICONTM Hip System is designed for total hip arthroplasty. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-union of proximal femoral neck fractures. F. Other indications such as congenital dysplasia…

Read the full statement (108 words)

The HELICONTM Hip System is designed for total hip arthroplasty.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomnalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

The HELICONTM hip stem is indicated for cementless use. The HELICONTM acetabular shell component is indicated for cemented or cementless use.

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/K111472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111472

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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